- 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.
- Bachelors 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
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Senior Regulatory Affairs Specialist - Redwood City, United States - Nevro
Description
About Nevro:
Nevro (NYSE: NVRO) is a global medical device company headquartered in Redwood City, California. We are focused on delivering comprehensive, life-changing solutions that continue to set the standard for enduring patient outcomes in chronic pain treatment. The company started with a simple mission to help more patients suffering from debilitating pain and developed its proprietary 10 kHz Therapy, an evidence-based, non-pharmacologic innovation that has impacted the lives of more than 100,000 patients globally.
Nevros comprehensive HFX spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic trunk and limb pain and painful diabetic neuropathy. Senza, Senza II, Senza Omnia, and Senza HFX iQ are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. HFX iQ, Nevros latest innovation, is the first and only SCS System that uses Artificial Intelligence to optimize and maintain pain relief using each patient's response1.Nevros unique support services provide every patient with an HFX Coach throughout their pain relief journey and every physician with HFX Cloud insights for enhanced patient and practice management.
Nevro also recently added a minimally invasive treatment option for patients suffering from chronic sacroiliac joint ("SI joint") pain and now provides the most comprehensive portfolio of products in the SI joint fusion space, designed to meet the preferences of physicians and varying patient needs in order to improve outcomes and quality of life for patients.
Job Summary & Responsibilities:(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.
#LI-JS1
Role Requirements:$99,361 - $136,621. The final starting salary offer to the successful candidate will be determined by evaluating several factors, such as education, experience, knowledge, skills, internal equity, alignment with market data, and geography. *Nevro is a multi-state employer, so the target pay range may increase or decrease depending on the city/state.
Full-time Nevro team members enjoy a full suite of additional benefits such as market-leading medical, dental, and vision benefits, 401k matching, ample vacation time, pre-tax savings perks, tuition reimbursement, Employee Stock Purchase Plan (ESPP), short and/or long-term incentive opportunities, recognition awards, volunteer time off, and several employee resource groups that focus on supporting our Wellness, Leadership Development, and Diversity and Inclusion.
EEO Statement: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, protected veteran status, disability, age or other characteristics protected by laws.
