Senior Regulatory Affairs Specialist
US-CA-Redwood City
Job ID: 2024-4477
Type: Regular Full-Time
# of Openings: 1
Category: Clinical & Regulatory
HQ
Overview
(Must currently live in the SF Bay Area)
The Senior Regulatory Affairs Specialist is responsible for developing strategies for global approvals to introduce new Spinal cord stimulation systems to market, maintain existing products, provide advice on regulatory requirements, prepare worldwide submissions, and negotiate their approval with global regulatory agencies.
- 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.
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Responsibilities- 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)
Qualifications- 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
Nevro offers equal employment opportunity, regardless of race, color, creed, religion, national origin, marital or family status, sex, sexual orientation, gender expression (including religious dress and grooming practices), gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), physical or mental condition, disability, age or other characteristics protected by laws.
PI240844884
