Director, Global Regulatory Affairs

Pay $190000.00 - $262000.00 / year

Location:

Redwood City, California

Employment type:

Other

• Req#: 4180

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.

In this high impact role, you will be responsible for all aspects of regulatory affairs, including strategic and operational leadership relative to the direction, planning, execution and conduct of Nevro’s regulatory objectives. Ensure compliance with applicable regulations and SOPs, and in accordance with expected timelines and budgets. Provides functional leadership, management and development to others within the Regulatory Department. This is a hands-on position.

Essential high impact responsibilities:

• Prepare and execute worldwide regulatory strategies/plans, both short term and long range.
• Manage regulatory team with oversight for day to day department responsibilities.
• Lead and participate in regulatory strategy formulation working closely with Clinical, Market Access, R&D, and Quality teams.
• Generate or direct regulatory affairs specialists in the preparation of submissions (i.e. PMA, 510(k), PMA supplements, CE marking applications, product registrations, etc.) to obtain various worldwide approvals to commercially distribute products. Oversee the subsequent submissions (annual reports, change notifications, etc.) to facilitate the maintenance of these approvals.
• Present project updates during team meetings and updates to senior management.
• Provide ongoing support to product development.
• Participate or direct the staff in the engineering change order process, by reviewing engineering and manufacturing document release and changes.
• Review and provide input to labeling and marketing programs in reference to regulatory requirements.
• Keep abreast of new developments in various regulations and advise senior management as necessary.
• Interface with regulatory agency representatives as needed to accomplish the above tasks.

• B.S. in scientific discipline or engineering.
• Experience with Class III Active Implantable Device required.
• 10+ years of progressive and demonstrably successful regulatory experience leading to successful regulatory clearances/approvals and product launches.

• Experience coaching, developing and managing experienced RA professionals.
• Good working knowledge of U.S. FDA, Canada and EU regulations and standards.
• Broad working knowledge of GCP, GMP, GLP.
• Excellent interpersonal, communication (written and oral), teamwork, leadership, organizational and negotiating skills.
• Ability to execute complex, multi-disciplinary projects and related activities coupled with strong analytical skills.
• Effective oral and written communication, interpersonal & influencing skills.
• PC skills, including word processing, spreadsheets, project management, etc.

Bay area pay range: $190,000 to $262,000. 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…