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Quality Assurance and Regulatory Affairs Specialist
2 months ago
Job Title: - General Quality & Regulatory Affairs Expert 2
Location: St. Louis, MO- Hybrid –(2-3 days on-site)
Duration: 12+ Months (possibilities of extension)
Job Overview:
As a Regulatory Affairs Expert in the Medical Devices sector, you will oversee various regulatory responsibilities with minimal oversight. Your role will involve managing health authority notifications, submissions, and registrations for both new and existing products, ensuring compliance with all relevant regulations while aligning with the broader corporate regulatory strategy.
Key Responsibilities:
1. Independently compile and maintain technical documentation and regulatory files to facilitate timely registrations and renewals.
2. Develop and manage a comprehensive library/database of technical documentation.
3. Stay updated on the status of applicable standards and regulations, conducting reviews and analyses as needed.
4. Assist in regulatory compliance activities, focusing on In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR) and ensuring adherence to FDA 21 CFR 820, CMDR SOR 98-292, ISO 13485:2016, and other international medical device regulations.
5. Review and update documentation requirements, ensuring necessary changes are implemented and communicated across the organization.
6. Oversee regulatory reviews for CAPA investigations, adverse events, validations, and other projects.
7. Prepare for and participate in audits conducted by regulatory authorities.
8. Analyze new registration requirements to assess their impact on business operations and document findings accordingly.
9. Address internal and external regulatory inquiries and requests.
10. Support recall or notification actions and manage regulatory vigilance reporting as required.
11. Serve as a liaison between the organization and internal/external representatives.
12. Maintain accurate records of registration activities and license modifications, adhering to Good Documentation Practices.
Minimum Qualifications:
- A Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, Engineering, or a related Life Science field.
- A minimum of 2 years of professional experience in Regulatory Affairs, specifically within the In Vitro Diagnostic (IVD) domain.
