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Senior Quality Assurance and Regulatory Affairs Specialist

3 weeks ago

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Quality Assurance and Regulatory Affairs Professional

We are seeking a highly skilled Quality Assurance and Regulatory Affairs professional to ensure compliance with relevant regulations and standards.

The successful candidate will be responsible for ensuring compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements. They will coordinate with regulatory authorities to obtain required permissions and approvals.

Key responsibilities include:

  • Ensuring compliance with relevant regulations and standards.
  • Coordinating with regulatory authorities to obtain required permissions and approvals.
  • Overseeing risk management, clinical evaluation, and post-market surveillance (PMS) for medical devices.
  • Managing regulatory submissions and ensuring timely approvals.
  • Handling Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
  • Supporting audits, inspections, and ensuring readiness for regulatory authority reviews.

The ideal candidate will have a strong understanding of quality systems and regulatory frameworks, hands-on experience with regulatory submissions, PMS, and risk management, excellent knowledge of GMP, GDP, and ISO 13485 standards, and strong communication, documentation, and coordination skills.

Candidates must possess strong analytical and problem-solving skills, with the ability to think critically and strategically. They should also be able to work effectively in a team environment and communicate complex information to stakeholders.

Job Requirements:

  • 5+ years of experience in Quality Assurance and Regulatory Affairs.
  • Strong knowledge of ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
  • Experience with regulatory submissions and post-market surveillance.
  • Excellent communication, documentation, and coordination skills.