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.

Responsibilities

• 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

Skills

• 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.

Compensation

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
• Regulatory Affairs Certificate desired