Sr. Regulatory Affairs Specialist

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.

Nevro's 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, and Senza Omnia are the only SCS systems that deliver Nevro's proprietary 10 kHz Therapy. Nevro's 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.

Job Summary & Responsibilities

Nevro Redwood City, California (onsite position)

Senior Regulatory Affairs Specialist, Redwood City, CA - Develop 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 approval with global regulatory agencies. Support cross-functional new product development projects and prepare and compile all materials required in submissions, license renewal and annual registrations.

Assist in maintenance and improvement of Nevro regulatory SOPs. Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance. Review Engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance.

Provide regulatory support during internal/external audits, BIMO inspections. Provide support for changes to existing products, including providing global regulatory assessment of changes, and subsequent regulatory filings. Interact and negotiate with regulatory agencies on defined matters as needed.

Apply knowledge of FDA and Medical Device Regulations (including 21 CFR Parts 11, 50, 54, 56, 803, 806, 807, 812, 814 and other FDA guidance), as well as EU MDD and/or EU MDR regulations, to Class II and Class III implantable or active implantable medical devices (including electrical/firmware and software devices). Prepare regulatory strategies/plans and ensure compliance with worldwide requirements. Author PMA or 510(k) submissions to include PMA and PMA supplements for US Class II and Class III medical devices. Prepare EU notified body submissions for CE marking. Monitor impact of new and changing regulations on submission strategies. (No agencies or phone calls please.) #LI-DNI

Role Requirements

Requires Master's degree in Biomedical Engineering, Biotechnology, Medical Devices and Diagnostic Engineering, Regulatory Affairs, Industrial Engineering, Mechanical Engineering, or a related field and 3 years of experience as a regulatory affairs specialist or related position or Bachelor's degree in Biomedical Engineering, Biotechnology, Medical Devices and Diagnostic Engineering, Regulatory Affairs, Industrial Engineering, Mechanical Engineering, or a related field and 5 years of experience as a regulatory affairs specialist or related position.

Must possess 3 years of experience with a Master's degree and 5 years of experience with a Bachelor's degree in the following:

Skills and Knowledge

• Working with US Class II and Class III implantable or active implantable medical devices (including electrical/firmware and software devices);

• FDA and Medical Device Regulations including 21 CFR Parts 11, 50, 54, 56, 803, 806, 807, 812, 814 and other FDA guidance;

• EU MDD and/or EU MDR regulations

• Leading and authoring PMA or 510(k) submissions to include PMA and PMA supplements for US Class II and Class III medical devices

• Leading and authoring EU notified body submissions for CE marking

Target Pay Range

$100,000 to $144,998

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.