What are the responsibilities and job description for the Sr. Regulatory Affairs Specialist position at Carlsmed?
About Carlsmed
Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.
Position Description
The Senior Regulatory Affairs Specialist will support the company's regulatory compliance efforts, ensuring that new and existing products meet global regulatory requirements. This role will focus on medical devices, including software as a medical device (SaMD) and additively manufactured spinal implants. The position will work closely with cross-functional teams and provide essential regulatory input during product development, submissions, and post-market surveillance activities.
This role is located in-office in Carlsbad, CA.
Responsibilities
- Write and submit 510(k)’s and interface with FDA during review process to ensure timely clearance
- Write software documentation in support of 510(k)’s such as software development plans, protocols and reports
- Participate and provide input for Design Control and Risk Management processes for varying projects
- Provide regulatory input into device verification and validation
- Review promotional marketing materials and labeling for users, hospitals, trade-shows, etc..
- Provide support during internal and external audits conducted by regulatory agencies or notified bodies
- Ensure that nonconformances, deviations, and post-market issues are adequately documented and resolved in compliance with regulatory guidelines
- Stay current with changing regulatory requirements
Qualifications
- Experience: 5-8 years of experience in medical devices; 5 years of experience in regulatory affairs; US 510(k) submission experience required
- Education: Bachelor’s degree required, preferably in Software Engineering or Biomedical Engineering
Skills
- Experience with software as a medical device (SaMD) and/or additively manufactured products is highly desirable; experience in spine or orthopedics device sector a plus
- Regulatory Affairs Certificate (RAC) desired
- Excellent verbal and written communication
- Desire to excel in a fast-paced MedTech startup; Ability to multi-task in a fast-paced environment
- Desire to be hands-on at all levels of tasks
- Self-directed, able to find answers on your own
- Ability to interface with executive management and effectively communicate and negotiate with regulatory bodies
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, age, veteran or disability status or other applicable legally protected characteristics. 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 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 and dental insurance premiums and a 401(k) plan with employer matching. The expected pay range is: $100,000 to $135,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.
Salary : $100,000 - $135,000
