Vice President, Quality and Regulatory Affairs

About Carlsmed

Carlsmed is a high growth medical technology leader and creator of the personalized spine surgery market with pioneering technology that is transforming spine surgery. The Company has developed the cutting-edge aprevo® Technology Platform that personalizes surgical procedures through a combination of proprietary AI-driven software and patient-specific fusion devices.

Position Description  

The Vice President of Quality and Regulatory Affairs will lead and oversee the company’s Quality and Regulatory functions, ensuring compliance with global regulatory requirements while driving continuous improvement across Quality Assurance, Quality Engineering and Regulatory Affairs. This role partners with the Leadership Team to develop and execute strategies that enable successful product development, market access, and ongoing quality assurance. You will work closely with cross-functional teams to align regulatory activities with company goals, advancing the Company’s implant and enabling technologies platforms.

Key Responsibilities:

• Lead the Regulatory Affairs and Quality Assurance (RAQA) functions, serving as the company’s Management Representative.
• Develop the regulatory strategy and personally create regulatory submissions to successfully secure market clearances for  new products in the U.S. and global markets.
• Act as a primary regulatory interface with FDA, leading meetings, communications, and negotiations to facilitate a clear and productive pathway to regulatory clearances/approvals. Facilitate effective communication with FDA in response to AINN requests.
• Provide mentorship, guidance, and strategic direction to RAQA staff, fostering a high-performance culture.
• Develop and implement integrated strategies to ensure compliance with both domestic and international regulatory requirements, including FDA and ISO standards.
• Maintain expert level understanding of quality and regulatory frameworks and adapt company practices to meet evolving requirements.
• Oversee planning and execution of quality and regulatory initiatives to support new product launches and process improvements.
• Partner with cross-functional teams, including R&D, Marketing, and Operations, to ensure seamless regulatory submissions, product launches, and process improvements.
• Stay informed of regulatory changes and emerging trends, proactively adapting strategies to maintain compliance.

Skills:

• Exceptional verbal and written communication skills.
• Strong ability to collaborate across functions and excel in a fast-paced MedTech startup environment.
• Aptitude for understanding complex technical concepts and translating them into actionable strategies.
• Strategic thinker with a detail-oriented approach to problem-solving and decision-making.

Qualifications:

• Bachelor’s degree in engineering, Science, or another Technical Discipline (advanced degree preferred).
• Minimum 10 years of medical device Quality and Regulatory Affairs experience, including a minimum of 5 years of people management experience and 5 years of experience in preparing 510(k) regulatory submissions.
• Experience engaging FDA DHT6B: Division of Spinal Devices, DHT6C: navigation, OHT6: Orthopedic Devices, and OHT8: radiological imaging
• RAC or ASQ certifications strongly preferred.
• Proven expertise in FDA regulations and ISO standards for medical devices.
• Successful track record of obtaining domestic and international device clearances/approvals.
• Experience in the spine or orthopedics device sector and Software as a Medical Device (SaMD) highly desirable.
• Exposure to both private and public company environments preferred.

Equal Opportunity Employer

Carlsmed is an equal-opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

Compensation

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families, including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. Compensation may vary based on related skills, experience, and relevant key attributes.