
Quality Assurance Specialist
2 days ago
Senior Quality Assurance and Regulatory Affairs Professional
Job DescriptionWe are seeking a skilled Senior Quality Assurance and Regulatory Affairs Professional to join our esteemed client in the Medical Device Industry.
The ideal candidate will have a strong understanding of quality systems, regulatory frameworks, and industry standards for medical devices.
This is an excellent opportunity for a motivated professional to grow their career while contributing to the success of our client's business.
Key Responsibilities:
- Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Coordinate with regulatory authorities such as FDA and CDSCO for obtaining required permissions and approvals.
- Oversee risk management, clinical evaluation, and post-market surveillance (PMS) for Class I, II, and III medical devices.
- Manage regulatory submissions and ensure timely approvals.
- Handle Corrective and Preventive Actions (CAPA) to maintain compliance and continuous improvement.
- Support audits, inspections, and ensure readiness for regulatory authority reviews.
To succeed in this role, you should possess:
- A strong understanding of quality systems and regulatory frameworks for medical devices.
- Hands-on experience with regulatory submissions, PMS, and risk management.
- Excellent knowledge of GMP, GDP, and ISO 13485 standards.
- Strong communication, documentation, and coordination skills.
This role offers a competitive salary package and opportunities for professional growth and development.
Other RequirementsPlease note that this is a full-time position, and the successful candidate will be expected to work independently and collaboratively as part of a dynamic team.
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