Senior Regulatory Affairs Specialist
Nevro Corp.
- Redwood City, CA
- $99,361-136,621 per year
- Permanent
- Full-time
- Support cross-functional new product development projects and lead compilation of all materials required in submissions, license renewal, and annual registrations.
- Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance.
- Provide support for changes to existing products, including providing global regulatory assessment of changes and subsequent regulatory filings.
- Prepare regulatory strategies/plans and ensure compliance with worldwide requirements. Provide ongoing support to project teams for regulatory issues and questions. Find, interpret, and apply regulations and guidance appropriately for situations.
- Develop solutions to a variety of technical problems. Actively participates in problem-solving discussions and recommends solutions.
- Monitor the impact of new and changing regulations on submission strategies.
- Experience in reviews of Engineering, electrical, software/firmware, manufacturing, sterilization, marketing, labeling, and clinical documents for regulatory compliance.
- Review advertising and promotional materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
- Keeps abreast with FDA and international guidance documents and regulations.
- Assist in the maintenance and improvement of Nevro regulatory SOPs.
- Ability to interact and negotiate with regulatory agencies on defined matters as needed.
- Provide regulatory support during internal/external audits and BIMO inspections.
- Other duties as assigned.
- Bachelor’s degree and a minimum of 4 years of experience in medical devices, OR Advanced degree in a scientific discipline with a minimum of 3 years of experience in medical devices.
- Experience working with Class III medical devices (PMA, IDE, EU MDR)
- This position is based at Nevro HQ location. Onsite travel required (3-4 days a week)
- Must demonstrate a history of successful Class III device submissions such as IDEs, PMAs, PMA supplements, 30-day notices, and Annual Reports in the US.
- Experience with FDA/EU requirements, guidance documents, Medical Device Directive, ISO 14971, and other relevant ISO standards.
- Experience working with Class III medical devices with electrical/firmware is a plus.
- Software as a Medical Device (SaMD) experience required.
- Medical Mobile Applications experience preferred.
- Experience with EU MDR submissions, amendments, and Change notifications to notified bodies.
- Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
- Ability to comprehend principles of engineering, physiology, and medical device use. Good analytical thinking skills.
- Strong communication and regulatory writing skills
- Project management skills
- Effective interpersonal skills
- Effective team member