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Senior Regulatory Affairs Specialist
1 month ago
*Hybrid on-site role in Valencia, CA - at least 1 day per week
The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for products globally.
Duties and Responsibilities
- Perform gap analyses between new/revised regulations and standards and the Quality Management System (QMS).
- Review and assess published literature, preclinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance.
- Compile Clinical Evaluation Plans and Reports.
- Assess reportability of changes to: labeling, design, materials, manufacturing process, sterilization or packaging.
- Working with other departments, gather data for completing Post-Market Surveillance Reports, Periodic Safety Update Reports, Critical Analysis Reports, Summary of Safety and Performance Reports, etc.
- Compile needed post-market reports.
- Facilitate the completion of actions identified as a result of post-market reports.
- Compile necessary documentation for the creation of technical files. Maintain technical files.
- Assist with writing submission documents for regulatory agencies (FDA, Health Canada, etc.) and Notified Bodies.
- Develop responses to questions or deficiency letters from regulatory agencies and notified bodies.
- Use technical/clinical writing skills to clearly describe technical information for third party reviewers.
- Perform submissions using the regulatory agency’s electronic submission process, if applicable (ESG, EUDAMED, etc.).
- Maintain registrations, certifications, and/or licenses, as applicable.
- Assist new product development teams to provide regulatory support to the project
- Develop positive working relationships with other departments.
- Actively participate in third party audits of.
Qualifications
- Medical Device experience (doesn’t need to be ortho, but have taken a device from feasibility thru market and post-market,) design control for at least 1 product line, US/EU MDR, International is a nice to have
- EU Experience: drafting technical files, corresponding with notified bodies, answering Q&A
- US Experience: 510ks, LTFs, interacting with FDA, resolving additional questions
- Hands-on contribution to authorship of 510(k) submissions