Quality Assurance Regulatory Affairs Manager

4 weeks ago

Pune, Maharashtra, India Frido Full time

Key Responsibilities:

Regulatory Compliance: Ensure adherence to ISO 13485, EN ISO 13485, USFDA, SFDA, UKCA, and CE certification standards.

Quality Management Systems (QMS): Implement and maintain robust QMS to comply with regulatory standards.

Technical Documentation: Prepare and review technical files for regulatory submissions, ensuring accuracy and completeness.

Risk Management: Apply ISO 14971 guidelines for risk assessment and mitigation in the product lifecycle.

Audits & Inspections: Conduct internal audits, manage external regulatory audits, and ensure readiness for inspections by authorities such as FDA, MHRA, and SFDA.

Change Management: Manage post-market surveillance, complaint handling, and CAPA (Corrective and Preventive Actions) processes.

Regulatory Strategy: Develop and implement compliance roadmaps tailored to various regulatory environments and markets.

Communication & Collaboration: Coordinate with regulatory bodies, notified bodies, and cross-functional teams to ensure seamless compliance.

Mandatory Skills:

In-depth expertise in ISO 13485, EN ISO 13485, USFDA, SFDA, UKCA, and CE certification processes.

Strong understanding of Quality Management Systems (QMS) and experience in their implementation and maintenance.

Proficient in technical documentation, particularly for regulatory submissions.

Hands-on experience in risk management practices, particularly ISO 14971.

Demonstrated ability to manage internal and external audits and liaise with regulatory authorities.

Experience in change management processes including CAPA, post-market surveillance, and complaints management.

Ability to develop and execute regulatory strategy for different markets.

Strong communication skills with a proven ability to collaborate effectively with cross-functional teams and external regulatory bodies.

Desirable Experience:

Prior experience managing audits and regulatory submissions with bodies such as FDA, MHRA, SFDA, etc.

Familiarity with software-based QMS tools and electronic documentation systems.

Strong problem-solving skills and ability to stay updated with evolving industry regulations.

Experience:

5-7 years of experience in Quality Assurance and Regulatory Affairs, particularly in the medical device industry.

Interested candidates can share their CV at

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