12 Fda Regulations Jobs

You will be joining a staffing company specializing in providing top talent to the Medical Device, Pharmaceutical, and Engineering industries as a Bench Sales Recruiter. Your role will involve conducting bench sales for professionals in these industries, focusing on job titles such as Quality Engineer, Manufacturing Engineer, Validation Engineer, and Regulatory Engineer. Building and maintaining relationships with existing clients and vendors, as well as acquiring new business opportunities, will be key responsibilities. You will need to stay updated on industry trends and regulatory requirements, and assist in the preparation of resumes for potential clients. To excel in this role, you should have a minimum of 2 years of bench sales experience in the Medical Device, Pharmaceutical, and Engineering sectors. Strong industry contacts and a proven track record of acquiring new clients and vendors are preferred. Your self-motivation, work ethic, and desire to succeed will be crucial, along with excellent communication and negotiation skills to connect with candidates and clients. Knowledge of Medical Device and Pharmaceutical FDA regulations is a bonus. In return, you can expect competitive incentives, insurance coverage, cab dropping facility for females, and provided food. This is an outstanding opportunity for a talented Bench Sales Recruiter who is passionate about connecting top talent with leading companies in the Medical Device, Pharmaceutical, and Engineering fields. If you are skilled at acquiring new business and value working with a company that appreciates your expertise, we invite you to apply for this role.,

ValGenesis is a leading digital validation platform provider for life sciences companies, catering to 30 of the top 50 global pharmaceutical and biotech companies. ValGenesis plays a crucial role in enabling digital transformation, ensuring total compliance, and enhancing manufacturing excellence/intelligence throughout the product lifecycle. As a Senior Validation Engineer at ValGenesis, you will play a vital role in maintaining the compliance and quality of our innovative software solutions designed for the life sciences sector. Your responsibilities will include collaborating with various teams to develop comprehensive validation strategies, creating and executing test cases, and upholding the project's quality standards. Your responsibilities will involve hands-on work in an individual capacity to deliver results. You will work closely with Product, Engineering, and Testing teams to understand product functions. This will include reviewing various product requirements such as Epics, User stories, User Requirements, and Software Requirements. The creation of test cases in OQ and PQ protocols following QMS guidelines, as well as the generation of realistic test cases and test data based on customer usage scenarios, will be part of your tasks. Executing test cases, documenting defects and deviations, and reporting test results will also be essential. Peer reviewing test cases, test data, and test designs will be part of maintaining the project's quality standards. Moreover, you will be required to work in a highly collaborative team environment with effective communication across multiple team members. A good understanding of the company's QMS standards and authoring documents in accordance with QMS guidelines are key aspects of the role. You will also lead a team of individuals, providing guidance, allocating work, reviewing work, and managing the validation of a product to ensure delivery quality and timelines are met. To qualify for this position, you should hold a BE/BS degree or possess equivalent work experience in Computer Science, Biology, Biomedical, or a related field. A minimum of 5 years of experience in Computer System Validation and Product Software Validation testing in a regulated environment is essential. Knowledge of the Product development life cycle, GMP, FDA, and ISO regulations is required. Additionally, familiarity with testing tools, Microsoft Office products, and the ability to quickly learn new concepts, technologies, and products are crucial. Excellent interpersonal, writing, communication, and troubleshooting skills are necessary, along with a passion for testing, validation, and product quality. Lastly, you should be capable of training and assisting colleagues with less experience and leading small projects effectively. At ValGenesis, we are committed to innovation and continuous improvement. Our mission is to provide an end-to-end digital transformation platform that surpasses industry standards, ensuring compliance with evolving regulations and quality expectations. We prioritize customer success and collaboration within our team, fostering a culture of open communication and support. By thinking big and aiming for excellence, we are on a trajectory to become the top intelligent validation platform in the market, setting high standards for ourselves and our industry peers.,

At Medtronic, you can embark on a life-long journey of exploration and innovation, all while advocating for healthcare access and equity for all. Your leadership will be purpose-driven, aimed at removing barriers to innovation in a more interconnected and compassionate world. You will be responsible for both manual and test automation tasks, engaging in Sprint planning, understanding project scope and timelines, and developing automation scripts based on feature requirements. Collaboration with system and software teams is crucial, ensuring adherence to testing protocols and conducting traceability analysis to ensure all requirements are met. Proactively identifying technical limitations and proposing solutions will be part of your role, along with understanding technological and V&V challenges in detail. Reporting to the Engineering Manager, you will interface with the V&V Lead and collaborate frequently with team members from various disciplines, including hardware engineers. Your role may involve interactions with clinicians, third-party vendors, manufacturers, subcontractors, and other users to develop project requirements and schedules. The ideal candidate will have 5-7 years of software testing experience, preferably in the medical device industry, and at least one year of test automation experience. A degree in Computer Sciences, Electronics, or Electrical Engineering is required, with additional preference given to candidates with advanced degrees in the same fields. Key skills include experience in manual testing, analyzing requirements, deriving test cases, identifying gaps or ambiguities in requirements, working on Ubuntu/Linux and/or Windows Applications, and using Requirements Management and configuration management tools. Proficiency in modern software testing tools, object-oriented programming, scripting/programming languages like Python and JavaScript, and knowledge of regulatory industry practices are advantageous. Medtronic offers competitive salaries and a flexible benefits package, reflecting a commitment to employee well-being and success. As a global healthcare technology leader, Medtronic focuses on addressing complex health challenges and improving lives worldwide through innovative solutions. The mission to alleviate pain, restore health, and extend life unites a diverse team of passionate individuals dedicated to engineering extraordinary solutions for real people.,

As a Medical Writer II specializing in QC of Regulatory Documents at Syneos Health, you will be responsible for compiling, writing, editing, and coordinating medical writing deliverables that present scientific information clearly and accurately. Your role will involve working within and across departments with minimal or moderate supervision to complete a variety of documents such as clinical study protocols, clinical study reports, patient narratives, investigator brochures, and more. You will adhere to established regulatory standards, including ICH E3 guidelines and company standard operating procedures, while completing medical writing projects on time and within budget. Additionally, you will coordinate quality and editorial reviews, manage source documentation, and act as a peer reviewer to ensure scientific content, clarity, consistency, and proper format of documents. In this role, you will interact with clients, department heads, and peers to produce high-quality writing deliverables. You will conduct online clinical literature searches, propose solutions to document issues, mentor less experienced medical writers, and maintain a strong working knowledge of drug development processes, regulatory guidelines, and industry best practices. The ideal candidate for this position should have a Bachelor's degree in a relevant discipline with at least 2 years of experience in science, technical, or medical writing. A graduate degree is preferred, and experience in the biopharmaceutical, device, or contract research organization industry is advantageous. Familiarity with FDA and ICH regulations, good publication practices, and the AMA Manual of Style is desired. In this dynamic role at Syneos Health, you will have the opportunity to contribute to the development of innovative therapies and make a meaningful impact on patient lives. If you are passionate about translating clinical insights into tangible outcomes and thrive in a collaborative and fast-paced environment, we invite you to join our team and be part of a global organization committed to customer success and employee well-being.,

As a Medical Writer II (Clinical Trial Transparency) at Syneos Health, you will play a crucial role in compiling, writing, and editing medical writing deliverables. Your responsibilities will include mentoring less experienced medical writers, developing various documents such as clinical study protocols, clinical study reports, patient narratives, annual reports, and investigator brochures with minimal supervision. You will review statistical analysis plans and table/figure/listing specifications for content, grammar, format, and consistency. Collaboration with department heads and staff in data management, biostatistics, regulatory affairs, and medical affairs will be essential to produce high-quality writing deliverables. You will also serve as a peer reviewer to ensure scientific content accuracy, clarity, overall consistency, and proper format. Adherence to established regulatory standards, including ICH-E3 guidelines, Company Standard Operating Procedures, and client standards is paramount. Your role will involve performing online clinical literature searches, maintaining a working knowledge of the drug development process and regulatory guidelines, and continuing professional development to stay informed about regulatory guidance affecting medical writing. In this role, you will be expected to work within budget specifications for assigned projects and communicate any changes to medical writing leadership promptly. Completing required administrative tasks within specified timeframes and performing other work-related duties as assigned will be part of your responsibilities. Some minimal travel may be required, typically less than 25%. To qualify for this position, you should have a Bachelor of Science degree with relevant writing experience or a Bachelor of Arts degree in Social Sciences, English, or Communications with scientific and/or medical knowledge. Proficiency in English grammar, FDA and ICH regulations, and familiarity with AMA style guide is necessary. Effective presentation, proofreading, interpersonal, and leadership skills are essential for this role, along with a team-oriented approach. If you are passionate about making a meaningful impact in the field of medical writing and are eager to contribute to the development of cutting-edge therapies, Syneos Health offers a dynamic and supportive work environment where your contributions will be valued and recognized. Join us in our mission to accelerate customer success and transform lives through innovative medical writing practices.,

As the Regulatory Affairs Manager at Natural Biogenex Pvt. Ltd. (NBPL), you will be responsible for overseeing the regulatory submission processes, ensuring compliance with all applicable regulations, and managing the regulatory strategy for pharmaceutical products. Your role will involve working closely with various departments such as R&D, Quality Assurance, and Marketing to facilitate the development and commercialization of pharmaceutical products. Your key responsibilities will include developing and implementing regulatory strategies for drug development and approval, guiding regulatory requirements and compliance to internal teams, preparing and submitting regulatory documents to health authorities, managing communication with regulatory authorities, monitoring changes in regulations to ensure compliance, working collaboratively with cross-functional teams, managing multiple regulatory projects simultaneously, and maintaining accurate records of regulatory submissions and communications. To excel in this role, you should possess a Bachelor's or Master's degree in pharmacy, along with a minimum of 12 - 15 years of experience in regulatory affairs within the pharmaceutical industry for filing products in various regulatory agencies. You should have a strong understanding of regulatory guidelines and compliance requirements (such as FDA, EMA, etc.), excellent communication, organizational, and project management skills, and the ability to work collaboratively in a fast-paced environment. By joining Natural Biogenex Pvt. Ltd., you will have the opportunity to be a part of a leading API manufacturing company with cutting-edge technology and compliance standards. You will work in a state-of-the-art Quality Control Laboratory with global regulatory standards, contribute to regulatory audits and pharmaceutical quality excellence, and benefit from competitive salary and professional development opportunities.,

As a key member of the team, you will be responsible for supporting daily DSCSA operations, which include product serialization, traceability, and exception handling. Your role will involve coordinating with internal teams such as QA, IT, Logistics, as well as external partners like CMOs, 3PLs, and wholesalers to ensure accurate product data exchange. In this position, you will play a crucial role in monitoring and investigating DSCSA compliance issues, such as "data no product" and "product no data" exceptions. You will also be responsible for ensuring the accurate and timely submission of T3 data, which includes Transaction Information, Transaction History, and Transaction Statement. A significant part of your responsibilities will include reconciling all outbound shipments from the 3PL using the middleware system to guarantee compliance with DSCSA guidelines. Additionally, you will need to maintain records of DSCSA-related activities in compliance with FDA regulations. You will also provide support in system testing, documentation, and implementation of serialization and verification solutions, such as EPCIS and VRS. It will be essential for you to stay updated on evolving FDA DSCSA regulations and industry best practices to ensure compliance. As part of your role, you will participate in audits, inspections, and readiness exercises to contribute to the overall compliance efforts of the organization. Your attention to detail, ability to collaborate with cross-functional teams, and commitment to staying informed on regulatory changes will be critical to success in this position.,

As a qualified candidate for this role, you should possess a Graduate or Post Graduate degree in Food Science, Technology, Microbiology, Chemical, Process Engineering, or a related field. Your academic background should be coupled with a minimum of 5 years of experience at the Assistant Manager level in Research & Development (R&D), particularly in the areas of Frozen Foods, Ready to Eat, Snacks, and Baking. An ideal candidate would also have a strong understanding and technical know-how of the Frozen Food industry. You should have experience and familiarity with multi-product technology and multi-location/cultural settings, encompassing Production, Quality, and other relevant areas. Your technical and functional skills should include a comprehensive knowledge of ingredients, processes, and technologies involved in the production of Frozen Foods, Ready to Eat items, Snacks, and Baking products. Additionally, a good understanding of FDA, EU, and FSSAI regulations, as well as proficiency in SAP, would be advantageous in this role. Furthermore, you should exhibit a solid commercial and operational understanding, including financial acumen, marketing strategies, and consumer insights. This role requires full-time commitment on a permanent basis, with a work schedule that may involve rotational shifts. An added benefit includes a yearly bonus. The work location for this position is on-site.,

Position Overview: We are seeking a highly qualified and experienced Director Clinical Research to lead and oversee clinical trials and research initiatives within our organization. The ideal candidate will have strong expertise in clinical research, particularly in oncology, and possess a deep understanding of global clinical trial regulations, study design, and execution. This role requires strategic thinking, team leadership, and the ability to manage multiple concurrent research projects in a fast-paced environment. Key Responsibilities: Leadership & Strategy: o Lead and oversee all clinical research activities, ensuring alignment with organizational goals and regulatory requirements. o Develop and implement clinical trial strategies, including protocol design, study planning, and risk mitigation. o Provide mentorship and guidance to clinical research teams and collaborators. Clinical Trial Management: o Oversee the planning, initiation, execution, and close-out of clinical trials. o Ensure compliance with FDA regulations, ICH GCP guidelines, and applicable local regulations. o Coordinate with CROs, investigators, and site staff for study implementation and monitoring. Regulatory & Compliance: o Prepare and review clinical protocols, Investigator Brochures (IBs), informed consent forms, and regulatory submissions. o Ensure ethical and regulatory compliance throughout all research activities. Data Analysis & Reporting: o Collaborate with biostatisticians and data managers to analyze clinical data. o Interpret study results and oversee preparation of study reports, publications, and regulatory documentation. Stakeholder Engagement: o Liaise with cross-functional departments including medical affairs, pharmacovigilance, and R&D. o Represent the organization in scientific meetings, regulatory discussions, and industry forums. Desired Candidate Profile: Educational Background: o Ph.D., MD, or MPH in a relevant scientific field such as biology, medicine, pharmacology, pharmacy, or public health. Experience: o Minimum 5-10 years of progressive experience in clinical research, with a strong track record in managing trials from concept to completion. o Prior experience in oncology research is highly preferred. o Experience working with global clinical trial regulations, particularly FDA and ICH GCP. Skills & Knowledge: o Excellent knowledge of clinical trial design, regulatory pathways, and protocol development. o Proficiency in statistical software (e.g., SAS, SPSS, R), data management tools (e.g., Medidata, Oracle Clinical), and relevant e-clinical systems. o Strong communication, leadership, and problem-solving skills. o Ability to work collaboratively in a cross-functional environment. Key Competencies: Strategic thinking and project leadership Clinical compliance and operational excellence Scientific acumen and data interpretation Team mentoring and stakeholder management Attention to ethical and quality standards

Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745). Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes. Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS). Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways. Provide regulatory guidance and support to internal teams and stakeholders, including communicating regulatory changes, conducting training on quality and regulatory requirements, and fostering a culture of compliance within the organization. Experience interacting with the FDA and other regulatory authorities. Excellent analytical skills and the ability to synthesize trending data into meaningful information for the organization.

Head of Engineering & Maintenance- will lead all engineering and maintenance operations for a large-scale API pharmaceutical plant. This role is responsible for ensuring the optimal performance, reliability, and compliance of plant equipment, systems, and facilities. The position requires extensive experience in API manufacturing, including expertise in CGMP, FDA regulations, and managing regulatory audits. Develop and execute maintenance strategies, drive continuous improvement, manage OPEX budgets, and lead a high-performing team to ensure safe, efficient, and compliant plant operations. LOCATION: Digwal, Hyderabad REPORTING STRUCTURE: Reports to Global Engineering & Project head & Site head , Direct reportees all plant engineering & maintenance team ESSENTIAL QUALIFICATION: Bachelors degree in Engineering (Mechanical, Electrical, or related field) RELEVANT EXPERIENCE: > 20 years in a Pharmaceutical API Facility Leadership & Strategy: Lead, manage, and develop the Engineering & Maintenance team to drive plant operational excellence. Develop and execute a comprehensive maintenance strategy, ensuring a proactive approach to maintenance, asset integrity, and equipment reliability. Drive continuous improvement initiatives to optimize plant performance and reduce unplanned downtime. Manage operating expenditure (OPEX) budgets for Engineering & Maintenance activities. Maintenance & Reliability Management : Ensure all critical equipment and systems are maintained in optimal condition to meet production goals and regulatory requirements. Oversee the implementation of preventive and predictive maintenance programs, improving plant uptime and reliability. Develop and implement a comprehensive asset management strategy, including lifecycle management for critical equipment. Regulatory Compliance & Safety : Ensure all maintenance activities are compliant with GMP, FDA, and other relevant pharmaceutical regulations. Promote a culture of safety and adherence to the highest environmental, health, and safety (EHS) standards. Lead the investigation and resolution of any maintenance-related incidents, ensuring timely and effective corrective actions. Team Development & Talent Management : Mentor, train, and develop Engineering & Maintenance personnel, ensuring their skills and capabilities meet the evolving needs of the plant. Foster a culture of collaboration, teamwork, and continuous learning within the team. Lead recruitment efforts to fill skill gaps within the department and drive talent development initiatives. Collaboration & Cross-Functional Coordination : Work closely with Production, Quality, and Supply Chain departments to ensure alignment between maintenance schedules and production plans. Collaborate with the plant leadership team to identify opportunities for process optimization, cost reductions, and productivity improvements. Technology & Innovation : Identify and implement new technologies that improve equipment performance, reduce maintenance costs, and enhance production efficiency. Stay current with industry best practices, technology advancements, and emerging trends in pharmaceutical manufacturing and maintenance Key Competencies: Must have extensive experience in API pharmaceutical manufacturing, with a deep understanding of CGMP, FDA regulations, and other regulatory audit requirements. Expertise in ensuring compliance with these standards while optimizing maintenance strategies and driving operational improvements is essential. The role requires a strong track record in managing audits, addressing non-conformities, and maintaining a high standard of product quality and safety.

Hiring Production Supervisor for a Medical Device Manufacturing company Job Title: Production Supervisor Medical Devices Location: Bengaluru Experience: 5 - 8 Years Department: Manufacturing / Operations Summary of the role: We are seeking a detail-oriented and proactive Production Supervisor to oversee the manufacturing operations of medical devices , with a specific focus on the X-ray tube production line . The role demands strong leadership, technical expertise in high-voltage components, vacuum processing, and precision assembly within cleanroom environments. The ideal candidate will ensure production efficiency, safety, and compliance with ISO 13485 , FDA 21 CFR Part 820 , and Good Manufacturing Practices (GMP) . Key Responsibilities Supervise and coordinate daily activities of production personnel to meet quality and productivity targets. Ensure strict adherence to quality systems ( ISO 13485 ) and regulatory requirements ( FDA 21 CFR Part 820 , GMP). Oversee end-to-end operations of the X-ray tube production line , including oil filling, vacuum sealing, and final encapsulation processes. Monitor production schedules, allocate resources effectively, and ensure timely completion of work orders. Identify, troubleshoot, and resolve production issues, implementing appropriate Corrective and Preventive Actions(CAPA) . Maintain complete and accurate production records, including batch documentation and Device History Records (DHR) . Train, coach, and evaluate production staff on SOPs, safety protocols, and regulatory compliance. Collaborate with cross-functional teams including Quality, Engineering, and Supply Chain to ensure smooth and compliant operations. Support internal and external audits and drive regulatory compliance initiatives. Continuously assess and improve production processes by contributing to Lean manufacturing , 5S , and Kaizen activities. Required Qualifications and Skills Bachelors Degree or Diploma in Engineering(Mechanical, Electrical, Biomedical, or related field). 5+ years of relevant experience in medical device manufacturing , preferably involving high-voltage and vacuum component production. Strong knowledge of ISO 13485 , GMP , FDA 21 CFR Part 820 compliance. Hands-on experience with cleanroom protocols, SOP documentation, and regulated manufacturing environments. Proficiency in handling CAPA, DHR documentation, and batch production reporting. Leadership experience in managing shop-floor teams and cross-functional collaboration. Familiarity with production planning systems and ERP tools is a plus. Key Competencies Leadership & Team Coordination Regulatory Compliance & Documentation Process Troubleshooting & Root Cause Analysis Continuous Improvement Mindset Strong Communication & Interpersonal Skills Attention to Detail and Quality Orientation For further information or any clarification, please reach us on rajbm@mlopssol.com