What are the responsibilities and job description for the Regulatory Affairs Specialist position at Carlsmed?
The 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.
Responsibilities
- Write and submit 510(k)’s and interface with FDA during review process to ensure timely clearance
- Support registrations for international markets, ensuring regulatory compliance with the relevant regulations
- Participate and provide input for design control and risk management processes for varying projects
- Provide regulatory input into device verification and validation
- 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: 2 years of experience in regulatory affairs for medical devices
- Education: Bachelor’s degree required
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
- Self-directed
- Excellent verbal and written communication
- Ability to multi-task in a fast-paced environment
- Desire to excel in a fast-paced startup
- Desire to be hands-on at all levels of tasks
- 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, 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: $85,000 to $105,000 annually. Compensation may vary based on related skills, experience, and relevant key attributes.
Salary : $85,000 - $105,000
