Vice President of Regulatory Affairs

2 weeks ago

Carlsbad, United States Spinal Elements Full time

About Spinal Elements

Spinal Elements is a Carlsbad, California-based medical device company focused on the design, development, and commercialization of a comprehensive portfolio of systems, products, and technologies for spine surgery procedures. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical procedures, Spinal Elements combines leading medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery. The company markets a complete portfolio of advanced spinal implant technologies. Learn more at


Meet the Team

The Vice President of Regulatory Affairs & Quality Assurance reports to the CEO and is a member of the Senior Leadership Team (SLT). This person will provide strategic direction and establish priorities for the Regulatory Affairs and Quality team and will work closely with all departments across the organization.


About the role:

As the Vice President of Regulatory Affairs and Quality Assurance at Spinal Elements, you will provide strategic direction for the Quality and Regulatory Affairs organization while establishing priorities that are aligned with company goals and objectives.


Core responsibilities include:

  • Identifying, assessing, and mitigating regulatory and quality risks.
  • Mentoring and developing team members to reach their full potential
  • Conducting training needs assessments to identify opportunities for service delivery improvement and value add to the company.
  • Interpreting regulatory rules or rule changes and ensuring that they are communicated through corporate policies and procedures.
  • Anticipating potential regulatory issues or risks and proactively offering solutions and strategies.
  • Updating internal procedures to ensure compliance with all national and international regulations.
  • Communicating with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Escorting government inspectors during inspections and providing post-inspection follow-up information as requested.
  • Coordinating, preparing, or reviewing regulatory submissions (IDE, 510(k), technical files, etc.) for domestic and international projects.
  • Other duties as assigned.



What Makes You Successful (KSA’s)

  • Strong verbal and written communication skills and the ability to effectively communicate and collaborate with internal and external stakeholders.
  • Strong interpersonal skills including the ability to remain calm, professional, diplomatic, and positive while under pressure.
  • Strong attention to detail while having the ability to handle multiple projects/tasks
  • Strong problem-solving skills and the ability to analyze complex issues and develop effective solutions.
  • Ability to work independently and as a member of a team in a timeline-driven environment with no direct oversight.
  • Strong decision-making skills and the ability to make sound decisions based on available data and expertise.
  • Strong change management skills and the ability to lead organizational change initiatives related to regulatory and quality.


What You’ll Get (Benefits & Perks)

  • 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


Experience and Education

  • 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.


Work Authorization

US Work Authorization required.


Physical Demands

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and the ability to adjust focus.


Work Environment

This job operates in an office setting.


Travel

Limited travel required; less than 10% of the time.


Spinal Elements is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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