Quality and Regulatory Affairs (QARA) Specialist

Job Summary

The Quality and Regulatory Affairs (QARA) Specialist will provide leadership in the quality and regulatory affairs function to understand regulatory requirements of medical devices, create relevant documentation and providing consultancy as an expert in regulatory affairs for IZiel clients. The RA specialist will work with clients in India and globally across USA and Europe to provide solutions for getting approvals for their products for launch in the Europe and USA. The candidate will require to go through extensive training in various country specific regulations as needed to keep themselves up-to-date with the latest and greatest updates as well as represent IZiel at various forums from time to time. The position will require support to make our clients highend products compliant to the new CE Medical Device Regulation (MDR).

Position Responsibilities

• Having extensive knowledge of regulatory pathways for medical devices approvals in various countries with primary focus on US & European regulatory pathways.
• Ability to research data and develop a regulatory strategy for approval of products for medical device manufacturers. Experience in creating and documenting a regulatory strategy successfully will be a plus.
• Should have knowledge of US FDA establishment registration and device listing.
• Ability to write 510(k) and PMA applications with relevant information and input from the engineer in teams.
• Experience with preparing design & development documentation to align with the regulatory strategy.
• Experience for compilation of technical file/design dossier as per US FDA and CE guidelines.
• Documentation per FDA and CE-MDR regulations and ISO standards.
• Perform audit compliances, analyzing gaps and shortcomings as per FDA/ISO regulations.
• File annual reports and manage regulatory changes per the respective FDA and CE mark guidelines.
• Understanding of cGMP regulations per 21 CFR and ISO 13485. Understanding of Risk Management per ISO 14971.

Desired/Preferred Qualifications

• Bachelor's with 8+ years of experience OR Master's with 6+ years of experience.
• Willingness to travel, if required
• Strong communication skills (written and oral)
• Team player
• Technical writing
• Experience in client coordination
• Experience with basic statistics and/or reliability methodologies.
• Detail oriented; ability to read various standards and guidelines and define implementation details.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.