Position Description:

Regulatory Affairs Specialist in Santa Rosa, CA. Provide worldwide premarket and post market regulatory affairs support for 21 CFR, EU Medical Device Directives, and other geographies. Utilizes EU and U.S. Class II and Class III device regulations and reportability decision tree matrix for product changes such as design changes, supplier changes, labeling changes. Make regulatory impact determination for product changes within the change management and documentation systems such as Regulatory Affairs Documentation (RAD) or Agile. Drafting, reviewing and supporting various pre-market submissions such as 510(k), IDE, original PMA, PMA Supplements, Design Dossiers and Supplements, Shonins and Partial Changes. Prepare and review various post-market submissions such as annual reports, 30-day notices, 5 day notices, post approval study reports, recertifications, and notifications to BSI for EU, and sending notifications for changes to all applicable geographies. Navigates the complexities of regulatory affairs for Class II and Class III medical devices in US and EU. Develops strategies for regulatory approval in US, EU, Japan, and Brazil by participating in medical device product development core group and contributing towards design and testing requirements and providing regulatory strategies. Reviews manufacturing changes, test protocols and verification and validation documents for appropriateness and compliance to regulatory requirements and laws. Ensure compliance to relevant regulations and standards per 21 CFR 11, 200, 210, 211, 800, 801, 803, 806, 807, 820, ISO 13485 and ISO 14971 requirements.

Basic Qualifications:

Master's degree in Regulatory Affairs/Science, Biomedical Engineering, Pharmacy or related medical clinical field and 6 months of experience in regulatory affairs*. Must possess a minimum of 6 months of experience* with each of the following: Preparing and reviewing pre and post market regulatory submissions for Class II and Class III medical devices in U.S. and EU; U.S. and EU Class II and Class III device regulations and reportability for product changes; medical device submissions and clearances including FDA medical device regulations and EU Medical Device Directive 2007/47/EC; d eveloping strategies for regulatory approval in U.S., EU, Japan, and Brazil; w orldwide regulatory requirements 510(k), IDE and PMA device product submissions; 21 CFR 11, 800, 801, 803, 806, 807, 809, 820, ISO 13485 and ISO 14971. *Experience maybe gained through internships, research, coursework and/or work experience

Additional Information

• Posting Date: Mar 1, 2021
• Travel: No