Regulatory Affairs Director
4 weeks ago
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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