Bachelor's or Master's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or related field
4-6 years of medical device regulatory affairs experience (3-5 with an advanced degree)
Strong knowledge of EU MDR 2017/745; familiarity with MDSAP, NMPA, TGA, and ANVISA
Hands-on experience with Technical Files, Design Dossiers, submissions, and 510(k)
Self-starter capable of leading submissions independently and connecting cross-functional teams
Must be authorized to work in the U.S. without visa sponsorship
Nice to have: RAC, clinical study support, medical device software regulations experience
Responsibilities
Develop and implement regulatory strategies for new products and modifications across various markets
Author and lead submissions including Technical Files, Design Dossiers, and 510(k)s
Act as the primary contact with Notified Bodies and global agencies for inquiries and audits
Provide regulatory input to cross-functional teams throughout the product lifecycle
Support post-market activities ensuring compliance with labeling and registrations
Review and approve change requests and assist with audits
Build and maintain regulatory procedures while mentoring junior team members
Benefits
Medical, dental, and vision coverage
401(k) with 4% matching contributions after 90 days
Basic Life and AD&D insurance
Unlimited vacation policy
6 weeks paid maternity leave
10 paid holidays
Collaborative and supportive work environment
Full Job Description
Job Description
Sr. Regulatory Affairs Specialist
Location: 100% On-site | Caldera HQ, Westlake Village, CA
Message from the Hiring ManagerThis role is for a regulatory professional who wants to own the work. You won't just process submissions. You'll set the global regulatory strategy for a fast-growing women's health portfolio and lead submissions from start to finish. You'll work across R&D, Quality, Clinical and Marketing, and your recommendations will shape how our products reach patients around the world. We're building and improving our regulatory processes right now, so you'll have real influence on how this function runs. Duties and Responsibilities:
Develop and carry out regulatory strategies for new products, modifications and renewals across EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT and other markets
Author and lead submissions: Technical Files/Design Dossiers, STED, CE Marking dossiers, change notifications, 510(k)s and country-specific registrations
Act as the main contact with Notified Bodies and global agencies, including inquiries, deficiency responses and audits
Give regulatory input to cross-functional teams across the full product lifecycle, from concept to end of life
Support post-market activities (vigilance, adverse event reporting, CAPA) and make sure labeling, UDI and registrations stay compliant
Review and approve change requests, protocols and reports, and help with ISO 13485, MDSAP and EU MDR audits
Build and maintain regulatory procedures and mentor junior team members
How Success is Measured
MDR and MDSAP certifications obtained and maintained
In-country licenses and registrations secured on time
Ongoing US and international compliance with no major audit findings
In your first 90 days: proven skill with our regulatory applications and a clear strategy for the portfolio
Qualifications:
Bachelor's or Master's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering or a related field
4-6 years of medical device regulatory affairs experience (3-5 with an advanced degree)
Strong working knowledge of EU MDR 2017/745; familiarity with MDSAP, NMPA, TGA and ANVISA
Hands-on experience preparing Technical Files, Design Dossiers and submissions, plus 510(k) and audit experience
A self-starter who can lead submissions independently, connect cross-functional teams and give clear, practical recommendations
Must be authorized to work in the U.S. without current or future visa sponsorship
Nice to have: RAC, clinical study support, medical device software regulations experience
Competitive Compensation, Comprehensive Benefits, and more!
Medical, dental and vision coverage
401(k) with 4% matching contributions after 90 days of employment
Basic Life and AD&D
Unlimited Vacation Policy
6 Weeks Paid Maternity Leave
10 paid holidays
Being surrounded by amazing people!
(This role is being filled internally, and we are not engaging external agencies at this time.)
