Team lead - Compliance

Job Description for the Role of Team Lead - Compliance

Job Title: Team Leader – Compliance

Department: Compliance

Location: Ambernath,

Experience Required: 7+ Years

Job Summary: The Lead – Regulatory Compliance is responsible for ensuring that the organization’s electronic medical and industrial devices comply with applicable domestic and international regulatory requirements. This role demands strategic oversight of regulatory submissions, audits, training, and quality system management, including US FDA, ISO 9001:2015, ISO 13485:2016, MDR 2017/745, MDR (India) and MDSAP. The position acts as a key liaison between regulatory authorities and internal departments, promoting a culture of compliance and continuous improvement.

Key Responsibilities:

1. Regulatory Strategy & Compliance

• Lead regulatory compliance efforts for medical and industrial electronic devices.
• Develop and implement regulatory strategies for product launches and global market expansion.
• Interpret and communicate evolving regulations (e.g., US FDA, ISO 13485, ISO 9001, MDR 2017/745, MDR (India), (MDSAP) to internal stakeholders.
• Ensure timely submissions and approvals from relevant regulatory authorities.

2. Product Lifecycle & Documentation

• Manage product registrations, submissions, and approvals for national and international markets.
• Maintain accurate documentation for audits, inspections, and regulatory submissions.
• Ensure traceability and control of all quality and regulatory documents.
• Oversee the implementation of regulatory requirements during product development and throughout the product lifecycle.

3.Quality Management System (QMS) Oversight

• Ensure QMS is implemented, maintained, and aligned with ISO 9001:2015, ISO 13485:2016, MDR (India), MDR 2017/745 and MDSAP standards.
• Promote awareness and compliance with regulatory requirements across departments.
• Plan, execute, and document periodic internal audits and ensure corrective actions are completed.
• Organize and lead Management Review Meetings (MRM), including agenda circulation, evidence recording, and action tracking.
• Submit MRM reports to top management.

4. Training & Competency Management

• Train employees on regulatory compliance, company policies, procedures, and best practices.
• Ensure personnel are competent, trained, and qualified for their roles.
• Conduct regular training sessions aligned with evolving standards and regulations.

5. Stakeholder Collaboration

• Collaborate with cross-functional teams (design, production, QA, marketing) to ensure products meet safety and regulatory expectations.
• Liaise with external regulatory bodies, notified bodies, and industry associations.
• Identify regulatory risks early and drive mitigation strategies.

6. Risk Management

• Lead the development and maintenance of risk management files in accordance with ISO 14971.
• Identify, assess, and mitigate regulatory and product-related risks throughout the lifecycle.
• Work cross-functionally to integrate risk controls into design, manufacturing, and post-market activities.

7. Clinical Evaluation

• Oversee preparation and maintenance of Clinical Evaluation Reports (CERs) in compliance with MDR 2017/745.
• Evaluate clinical data to demonstrate product safety and performance.
• Collaborate with medical experts, R&D, and external partners to gather relevant clinical evidence.
• Support Post-Market Clinical Follow-Up (PMCF) and surveillance activities as required.

8. Regulatory Audits & Inspections

• Prepare for and lead regulatory and customer audits (US FDA inspections, ISO audits, etc.).
• Respond to audit findings and ensure timely implementation of corrective/preventive actions.

9. Continuous Improvement & Risk Management

• Monitor industry trends, regulatory changes, and customer feedback to refine processes.
• Identify gaps or weaknesses in compliance systems and recommend improvements.

10. Confidentiality & Integrity

• Ensure that all confidential documentation and records with business impact are protected.
• Maintain integrity and transparency in all regulatory and compliance functions.

Qualifications & Skills:

• Bachelor’s or Master’s degree in Regulatory Affairs, Quality Management, or a related field.
• Minimum 7 years of experience in regulatory compliance, preferably in medical device or electronics manufacturing.
• Proven knowledge and experience with ISO 9001:2015, ISO 13485:2016, MDR-2017/745, MDR (India), MDSAP and US FDA (21 CFR Part 820, 510(K)).
• Strong leadership, problem-solving, and team management skills.
• Experience in regulatory submissions, audits, and compliance for global markets.
• Strong documentation, organizational, and project management skills.
• Ability to interpret complex regulatory requirements and translate them into actionable policies.
• Strong interpersonal and training abilities to lead cross-functional teams.
• Hands-on experience with audits (internal/external), QMS implementation, and regulatory submissions.

Job Type: Full-time

Pay: ₹400,000.00 - ₹1,204,891.35 per year

Benefits:

• Provident Fund

Ability to commute/relocate:

• Ambernath, Maharashtra: Reliably commute or planning to relocate before starting work (Preferred)

Experience:

• ISO 13485: 7 years (Preferred)

Work Location: In person