Sr Manager, Regulatory Affairs
Carlsmed
Job Summary
The Manager, Regulatory Affairs, is responsible for leading Carlsmed’s regulatory submissions and successfully interacting with regulatory agencies.
Responsibilities
- Lead the Regulatory Affairs function, including creation and/or oversight of US and International regulatory submissions.
- Create effective and efficient 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 that regulatory submissions are timely and successful.
- Ensure regulatory compliance in change orders and design reviews.
- Recommend appropriate validation strategies that support a solid submission.
- Represent Regulatory Affairs in all Internal and Third-Party Audits (FDA, ISO, MDSAP).
- Administer and manage US and International registrations, device listings and US small business certification.
- Determine OUS country requirements for market entry.
- Responsible for the performance management and career development of direct reports.
Qualifications
- Education: Bachelor’s degree, preferably in engineering or technical discipline
- Experience: 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 and ISO 13485 standards
- Experience in spine or orthopedics device sector is highly desired
- Experience in both US and International market 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
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. The expected pay range is: $110K - $140K annually. Compensation may vary based on related skills, experience, and relevant key attributes.