5 Eu Regulations Jobs

Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Be part of something bigger! BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues. In BD Specimen Management (SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Senior Regulatory Affairs Specialist position is primarily focused on supporting regulatory sustaining activities within the SM organization, including providing support for change control activities and continued compliance with postmarket MDR and IVDR regulatory requirements. The ideal candidate will be energetic, possess strong regulatory technical knowledge (particularly in the area of change control), have experience supporting MDR and IVDR requirements, and perform well independently and as part of a team. Our people make all the difference in our success. Join us in our mission to advance the world of health. Support the Regulatory Affairs function on Product Lifecycle Management (PLM)/Sustaining project teams and liaise with Regulatory Affairs subject matter experts (SMEs) to fulfill US FDA and EU CE requirements. Assist in compiling, drafting and submitting the required submission documents to support 510(k) and/or CE Technical File Documentation, (eg STeD ) to obtain clearances and/or approvals to established timelines. Assist and manage Notification of Change (NOC)/International Regulatory Affairs assessments of PLM/Sustaining activities to ensure regional/country requirements of US, EU and Rest of World (ROW) are captured in Regulatory strategy development. Develop regulatory strategies for Change Controls (CC) and establish Regulatory Requirements. Monitor completion of all CC task requirements recorded in the PEGA CC system and verify completion of requirements before Engineering Change Release ECRO release. Monitor and assess the impact of existing, modified and new standards pertaining to BD products for the US and EU markets and maintenance of related regulatory documentation. Support regulatory efforts to maintain and /or simplify technical documentation maintenance, labeling changes/remediations projects and UDI assessments. Review and approve labeling and promotional material for compliance to FDA and EU regulations. Support completion of EU Substantial Change Notifications and Substantial Change Applications for approval. Prepare responses to notified body inquiries. Prepare EU CE re-certification applications following notified body templates with supporting evidence from cross functional teams. Provide training or deliver presentations to cross-functional groups across TCI and SM on salient regulatory topics. Recognize potential compliance problems areas or associate ambiguity and make recommendations to resolve. Work independently and carries out the above tasks with minimal supervision. Education and Experience: B.S. degree in a scientific, health sciences or technical discipline (e.g., engineering, bioengineering, biology, chemistry). Minimum 5 years regulatory experience and working knowledge in regulated medical device or in vitro diagnostic device companies or an equivalence combination of experience with an advanced degree. Experience in preparing, approving and maintaining Technical Documentation and other submissions compliant with US, EU and global regulations. Experience in supporting product development projects for product and process changes. Demonstrated ability to participate on cross-functional team to consistently to meet regulatory requirements and project timelines. Proficient in using Microsoft Word, Excel, PowerPoint, and Project. Strong communication (written, oral) and project management skills. Able to handle multiple competing tasks with great attention to detail. Able to work independently to achieve objectives on or before schedule. Demonstrated cross-functional collaboration and teamwork skills including influencing without authority. Comprehensive knowledge of medical device regulations and standards. Current knowledge of European quality system standards, and requirements under EU MDR and IVDR preferred. Ability to navigate ambiguous regulatory requirements and standards interpretation.,

The role you are applying for will involve coordinating with Group CISO & the Asia Pacific Region (APR) Risk Management team to implement central directives regarding cybersecurity governance, conducting analysis, and organizing committees within APR. This position will report directly to the Regional Head of Risk Management, Asia Pacific Region (APR). The ideal candidate for this role should have experience working as a Chief Information Security Officer (CISO) with a background in Cyber Security, Cyber Risk Management, and Risk Management. You will be responsible for managing the APR region (Asia Pacific/Europe) and should have prior experience working with APR countries or other Asian countries, primarily Europe. It is essential to have expertise in developing and executing security strategies. Candidates with a history of frequent job changes (e.g., almost every year) will not be considered. Knowledge of EU regulations, such as DORA, is advantageous. Certifications such as CISSP, CISM, or CISA are required for this position. Your main responsibilities will include adapting Group documents to enhance local cyber resilience, organizing quarterly regional ISS Committees, cascading risk mapping to the local level, supporting the assessment of local third parties" security, advising on local/regional IT and Cyber Projects, and overseeing cybersecurity regulations in Asia Pacific. You will also be involved in conducting Cyber Risk assessments at a regional level and other risk management activities as needed. Candidates should hold a bachelor's degree in information technology, computer science, or a related field. Professional qualifications such as CISSP, CISM, or CISA are necessary. A minimum of 10 years of experience in IT management/cybersecurity governance or related fields, preferably in financial institutions, is required. You should have a strong understanding of security principles, standards, and technologies, including access control, network security, identity management, and cyber incident management. The candidate should possess strong communication and interpersonal skills to collaborate effectively with stakeholders at all levels. Being well-organized, detail-oriented, a good team player, and capable of establishing and maintaining effective working relationships with internal stakeholders are essential attributes for this role. Additionally, you should be able to work independently and demonstrate strong self-motivation.,

The Know Your Client Key Operating Standards (KYC KOS), Associate position in Bangalore, India at Deutsche Bank involves setting, maintaining, and governing the minimum operational standards for key processes utilized by KYC Ops. The KYC Team, managed from London and Frankfurt, with a global presence in Singapore, India, Birmingham, and Jacksonville, ensures client due diligence compliance with KYC and Sanctions Policy and relevant laws. In this role, you will support key stakeholders in understanding KYC and Sanctions Policy requirements and translating them into minimum standards for implementation by KYC Ops. You will address queries, assist in policy-driven change initiatives, and create clear guidance documents. Collaboration with AFC and Sanctions Policy teams, providing real-time advisory, and ensuring proper documentation of KOS requirements are key responsibilities. The position requires a working knowledge of KYC and Sanctions Policies, especially German and EU Regulations, along with experience in supporting policy change management. Proficiency in English language, willingness to embrace new technology solutions, and strong communication skills are essential. The role also offers various benefits under a flexible scheme, including leave policy, parental leaves, childcare assistance, sponsorship for certifications, and more. As part of Deutsche Bank, you will receive training and development opportunities, coaching from experts, and a culture of continuous learning. The company values responsible actions, commercial thinking, initiative, and collaborative work. Applications from all individuals are welcomed to promote a positive and inclusive work environment within the Deutsche Bank Group.,

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.,

As a member of our Medical Device team, you will not only manage a small team of globally based Product Assessors but also dive deep into the exciting world of Active Medical Devices. Your responsibilities will include: Supporting and guiding your team of talented Product Assessors Conducting thorough technical documentation reviews and ensuring compliance with EU regulations and standards. Collaborating with cross-functional teams to increase efficiency and quality Monitoring the teams technical competence, KPIs, and wellbeing and providing feedback and support when there are concerns. Conduct recruitment, including reviewing CVs and undertaking interviews and supporting with onboarding of new starters Develop training and present the training to others in SGS or externally as deemed necessary. Assist with technical queries and those related to sales within the Active Medical Devices field. Ensure that the highest level of service is provided throughout the SGS network offering medical devices certification and stakeholders through efficient service delivery.