Quality Assurance Regulatory Affairs Manager

Frido; Pune District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A leading medical device company is looking for a Quality Assurance Regulatory Affairs Manager to ensure compliance with ISO standards and manage regulatory submissions. The ideal candidate will have 5-7 years of experience in Quality Assurance, specifically in the medical device industry, and a strong understanding of QMS and regulatory practices. Interested candidates are encouraged to apply via email.

Qualifications

• 5-7 years of experience in Quality Assurance and Regulatory Affairs, particularly in the medical device industry.
• Proficient in compliance with ISO 13485, USFDA, and other regulatory standards.
• Strong understanding of audit management and regulatory submissions.

Responsibilities

• Ensure adherence to ISO 13485 and other certification standards.
• Implement and maintain Quality Management Systems.
• Prepare and review technical files for regulatory submissions.
• Conduct internal and external audits, manage regulatory inspections.
• Develop compliance roadmaps for various regulatory environments.

Skills

ISO 13485 expertise

Quality Management Systems (QMS)

Technical documentation for regulatory submissions

Risk management practices

Change management processes (CAPA)

Regulatory strategy development

Communication skills

Software-based QMS tools

Problem-solving skills

Job description

Quality Assurance Regulatory Affairs Manager

Location: Pune

Key Responsibilities:

• Ensure adherence to ISO 13485, EN ISO 13485, USFDA, SFDA, UKCA, and CE certification standards.
• Implement and maintain robust QMS to comply with regulatory standards.
• Prepare and review technical files for regulatory submissions, ensuring accuracy and completeness.
• Apply ISO 14971 guidelines for risk assessment and mitigation in the product lifecycle.
• Conduct internal audits, manage external regulatory audits, and ensure readiness for inspections by authorities such as FDA, MHRA, and SFDA.
• Manage post-market surveillance, complaint handling, and CAPA (Corrective and Preventive Actions) processes.
• Develop and implement compliance roadmaps tailored to various regulatory environments and markets.
• 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.
• 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.

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

Interested candidates can share their CV at [e-mail].

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance

Industries

Medical Equipment Manufacturing, Wellness and Fitness Services, and Manufacturing