Regulatory Affairs Specialist

Job Locations US-CA-Redwood City
Job Post Information* : Posted Date 2 months ago(12/22/2022 11:56 AM)
ID
2022-3940
Category
Clinical & Regulatory

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 80,000 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

(Must live in the SF Bay Area)

 

Your regulatory background in Class II/III medical devices experience aligns well with our Regulatory Affairs Specialist (on-site 3 days/week in Redwood City, CA) opportunity.  You are a professional who wants to be at the center of disruptive medical technology with Bluetooth and AI, where innovation and passion collide.  You will develop regulatory strategies for new products, while ensuring regulatory submissions and compliance for existing commercial portfolio. 

  • You are responsible for regulatory submissions and regulatory compliance for currently marketed products, as necessary, to ensure ongoing compliance
  • Regulatory representative on core teams providing regulatory input and guidance throughout the product development cycle.
  • Work on development of pre-submission strategy/regulatory pathway, provide input on testing requirements for new and modified product.
  • Assess software, product design, manufacturing, packaging, sterilization, and labeling changes for compliance with applicable regulations and prepare submissions, as required for applicable geographies; analyze and recommend appropriate changes.
  • Responsible for preparation and submission of regulatory applications and reports for FDA, EU and other regulatory agencies, as well as internal regulatory file documentation.
  • Work closely with cross functional team members in quality, clinical and R&D as required on projects to write submissions as well as resolve regulatory agency questions
  • Review and sign-off on product and manufacturing changes for compliance with applicable regulations.
  • Keep abreast of regulatory procedures and changes as well as evolving regulatory landscape
  • Actively participates in problem solving discussions and recommends solutions.
  • May require direct interaction with regulatory agencies on defined matters.
  • Provide support during internal and external audits
  • Support and maintain Quality initiatives in accordance with Nevro Quality Policy.

Role Requirements

  • Bachelor’s/Advanced degree and minimum 2 years of experience in medical device regulatory affairs
  • Experience with Class II/III medical devices (510(k), PMA, IDE)
  • Experience working on EU MDR submissions/amendments preferred
  • Software as a Medical Device (SaMD) experience preferred
  • This position is based at Nevro HQ location

Skills and Knowledge

  • Working knowledge of FDA, EU MDR and international regulations for medical devices.
  • General understanding of product development process and design control.
  • Ability to comprehend and apply principles of engineering, physiology and medical device use
  • Ability to effectively manage multiple projects and priorities
  • Effective research and analytical thinking skills.
  • Effective team member
  • Effective written and oral communication, technical writing and editing skills.
  • Ability to work independently with minimal supervision
  • Proficiency with Microsoft Office.

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Target Pay Range

$80,528 - $110,726. 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.

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