*Hybrid on-site/remote position in Carlsbad, CA
The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products, including Software technologies; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions.
Essential Duties and Responsibilities
- Collaborates as a core team member on new product development teams. Determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.
- Supports and assists in FDA (510(k)), EU (MDR) and ROW regulatory submissions for new product approvals involving software.
- Provides input on domestic and OUS regulatory strategies for products containing software, and software as a medical device (SaMD).
- Assists regulatory leadership in ensuring IEC 62304 requirements are applied in the development and improvement of the software lifecycle processes for domestic and OUS submissions.
- Evaluates design changes to products to determine impact to submissions and potential need for additional submissions.
- Assists with post-market surveillance evaluation, trending, and reporting, including updates to risk management (FMEA) process.
- Reviews product labeling and promotional materials to ensure consistency with regulatory approvals.
- Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
- Provides department support during internal and external audits.
- Develops and revises department SOPs/SWIs to ensure compliance with applicable global regulatory requirements.
- Maintains FDA establishment listings and registration.
- Other duties as assigned.
- Typically requires a bachelor's degree and 2-3 years of experience in the medical device industry.
- Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485, MDD 93/42/EEC, and EU MDR.
- Orthopaedic or spine experience preferred.
- RAC Certification is preferred.
- Must be detail oriented and have strong technical writing skills.
- Must possess strong interpersonal communication, teamwork and organizational skills.