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Medical Device Regulatory Compliance Specialist
2 weeks ago
Quality Assurance and Regulatory Affairs Specialist
Job Description:
We are seeking an experienced Quality Assurance and Regulatory Affairs Specialist to join our organization in the Medical Device Industry. The ideal candidate will have a strong understanding of quality systems and regulatory frameworks for medical devices.
Key Responsibilities:
- Ensure compliance with ISO 13485, MDD, MDR, GMP, GDP, and QMS requirements.
- Coordinate with local 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.
Required Skills and Qualifications:
- 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.
Benefits:
The successful candidate will have the opportunity to work in a dynamic environment with a team of professionals dedicated to delivering high-quality products.
Other Information:
Applicants should have a bachelor's degree in a relevant field and at least 5 years of experience in quality assurance and regulatory affairs. If you are a motivated and detail-oriented individual who is passionate about quality and regulatory compliance, we encourage you to apply.
