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Strategic Regulatory Affairs and Quality Assurance Leader

2 months ago

Carlsbad, United States Spinal Elements Full time
About Spinal Elements

Spinal Elements is a leading medical device company focused on 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 and strategic Regulatory Affairs and Quality Assurance leader to join our team at Spinal Elements.

The successful candidate will provide strategic direction and establish priorities for the Regulatory Affairs and Quality team, working closely with all departments across the organization.

Key Responsibilities
  • Regulatory Strategy and Planning
    • Develop and implement regulatory strategies to ensure compliance with national and international regulations.
    • Identify and mitigate regulatory and quality risks.
  • Team Leadership and Development
    • 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.
  • Regulatory Compliance and Quality Assurance
    • Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.
    • Update internal procedures to ensure compliance with all national and international regulations.
  • Regulatory Submissions and Communications
    • Coordinate, prepare, or review regulatory submissions (IDE, 510(k), technical files, etc.) for domestic and international projects.
    • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Quality System Compliance and Strategy
    • Develop and implement quality system compliance strategies to ensure adherence to ISO 13485, 21 CFR 820, MDSAP, and MDR.
Requirements
  • Education and Experience
    • 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.
  • Skills and Qualifications
    • 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 We Offer
  • Benefits and 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.