Carlsmed is seeking an experienced Regulatory Affairs Manager looking to join a progressive, early stage MedTech startup. Our mission is to utilize data to create personalized surgical plans and medical devices to greatly improve the standard of care for debilitating conditions. As RA Manager, you will work on regulatory projects related to proprietary implants, instrumentation and software.
Write and submit traditional and special 510(k), interface with FDA during review process
Advise executive management on regulatory pathways
Create regulatory strategy and plans
Ensure regulatory requirements are met. Participate in Design Control and Risk Management processes
Provide regulatory input to device testing and labeling
Provide regulatory input into QMS Development
Lead the reporting of adverse events to regulatory bodies
Stay current with changing regulatory requirements
Experience with Additively Manufactured devices is a plus
Experience with US, EU and ROW marketing authorization applications
Experience with or understanding of EU MDR requirements is a plus
Excellent verbal and written communication
Desire to excel in a fast-paced MedTech startup
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 board of directors
Ability to effectively communicate and negotiate with regulatory bodies
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.
At Carlsmed, our employees are our most valued asset. Our benefits reflect our investment in the overall health and well-being of our employees and their families. We pleased to provide a competitive salary and benefits, including paying 100% of monthly healthcare and dental insurance premiums and a 401(k) plan with employer matching.
Bachelor’s degree in Biomedical Engineering or Mechanical Engineering preferred
3 – 5 years of medical device regulatory affairs experience required
Experience in spine or orthopedics device sector highly desired
Experience with software as a medical device is a plus
Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The company’s aprevo® devices are personalized to improve the standard of care for the surgical treatment of adults with spinal malalignment. Carlsmed uses patient data and proprietary digital technologies to create optimal surgical plans and personalized aprevo® spine fusion devices to align with the surgeon’s goals for each patient.