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Vice President of Regulatory Affairs and Quality Assurance

2 months ago

Carlsbad, United States Spinal Elements Full time
About Spinal Elements

Spinal Elements is a leading medical device company based in Carlsbad, California, specializing in the design, development, and commercialization of innovative systems, products, and technologies for spine surgery procedures.

The company combines cutting-edge medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation for delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery.

Job Summary

We are seeking a highly experienced Vice President of Regulatory Affairs and Quality Assurance to join our Senior Leadership Team. This individual will provide strategic direction and establish priorities for the Regulatory Affairs and Quality team, working closely with all departments across the organization.

Key Responsibilities
  • Identify, assess, and mitigate regulatory and quality risks.
  • Mentor and develop team members to reach their full potential.
  • Conduct training needs assessments to identify opportunities for service delivery improvement and value add to the company.
  • Interpret regulatory rules or rule changes and ensure they are communicated through corporate policies and procedures.
  • Anticipate potential regulatory issues or risks and proactively offer solutions and strategies.
  • Update internal procedures to ensure compliance with all national and international regulations.
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Coordinate, prepare, or review regulatory submissions (IDE, 510(k), technical files, etc.) for domestic and international projects.
Requirements
  • Bachelor's degree in a relevant scientific or regulatory field; advanced degree preferred.
  • Minimum of 20+ years of experience in quality assurance and regulatory affairs within a regulated environment such as medical device or IVD; or an advanced degree and 15+ years of experience.
  • Minimum of 10+ years of management experience required.
  • A successful track record in preparing multiple 510(k) submissions and/or PMA submissions for medical devices.
  • Experience with international submissions and regulations including Brazil, Mexico, and Columbia.
  • Experienced in Quality System compliance and strategy.
  • Strong understanding of ISO 13485, 21 CFR 820, MDSAP, and MDR.
What We Offer
  • A full and comprehensive benefits program including medical, dental, vision, short-term and long-term disability, flexible spending accounts, and more.
  • Wellness program and Employee Assistance Program (EAP).
  • Retirement savings plan (401k) with company match.
  • Travel Assistance Program, Pet Insurance, and Legal Services.
  • 10 paid holidays and 1 floating holiday.
  • 15 days PTO.
  • Educational Assistance Program.
  • Hybrid work schedule.