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Quality Assurance Director

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At the forefront of quality assurance, we seek a visionary leader to spearhead our regulatory affairs initiatives.

The ideal candidate should possess 5-7 years of experience and hold a degree in pharmaceutical sciences, with relevant expertise in medical device regulation.

Key Responsibilities:
  • Ensure compliance with ISO standards, EU directives, and GMP requirements by coordinating with regulatory authorities and maintaining accurate records.
  • Oversee risk management, clinical evaluation, and post-market surveillance for Class I, II, and III medical devices, ensuring timely submissions and approvals.
  • Manage corrective actions to maintain compliance and continuous improvement, while supporting audits and inspections.

The successful candidate will have a deep understanding of quality systems and regulatory frameworks for medical devices, with exceptional communication, documentation, and coordination skills.