Regulatory Affairs Director

4 weeks ago


Carlsbad, California, United States Carlsmed Full time

Job Title: Regulatory Affairs Director

Job Summary:

The Regulatory Affairs Director at Carlsmed is responsible for leading the company's regulatory submissions and ensuring successful interactions with regulatory agencies. This role requires a strong understanding of US and international regulatory pathways and the ability to create effective and efficient regulatory strategies that support the company's mission and goals.

Key Responsibilities:

  • Lead the Regulatory Affairs function, including creation and/or oversight of US and international regulatory submissions.
  • Create regulatory strategies that support the company's mission and goals.
  • Determine and advise executive management on regulatory pathways domestically and internationally.
  • Collaborate with cross-functional leaders to ensure timely and successful regulatory submissions.
  • Ensure regulatory compliance in change orders and design reviews.
  • Recommend validation strategies that support a solid submission.
  • Represent Regulatory Affairs in internal and third-party audits.
  • Administer and manage US and international registrations, device listings, and US small business certification.
  • Determine OUS country requirements for market entry.
  • Perform performance management and career development of direct reports.

Qualifications:

  • Bachelor's degree in engineering or technical discipline.
  • 8 years of medical device Regulatory Affairs experience.
  • Software as a medical device experience is preferred.
  • Management experience is highly desired.
  • Expert working knowledge of US 510(k)s and pre-submissions.
  • Expert working knowledge of USFDA regulations and guidance documents.
  • Working knowledge of ISO 13485 standards.
  • Experience in spine or orthopedics device sector is highly desired.
  • Experience in both US and international markets required.
  • Able to effectively communicate with cross-functional team members and management.

Skills:

  • RAPS Certification in Medical Device is highly desired.
  • Demonstrated track record as an author of successful 510(k) submissions.
  • Ability to effectively communicate and negotiate with regulatory bodies.
  • Strong written and verbal communications skills.
  • Able to influence and guide direct reports and peers.
  • Able to mentor and train direct reports.
  • Excellent verbal and written communication.
  • Desire to excel in a fast-paced MedTech startup.
  • Self-directed and self-motivated.
  • Ability to multi-task in a fast-paced environment.

Benefits:

We offer a competitive salary and benefits package, including 100% of monthly healthcare, dental, and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range is $110K - $140K annually.



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