Sr. Regulatory Affairs Specialist

Caldera Medical•Westlake Village, CA

1d•Onsite

About The Position

Caldera Medical is hiring a Sr. Regulatory Affairs Specialist to own global regulatory strategy and lead regulatory submissions for its women’s health and neuromodulation product portfolio. Based 100% on-site at Caldera’s headquarters in Westlake Village, California, the specialist will work with R&D, Quality, Clinical, and Marketing and help develop and improve the company’s regulatory processes. The role covers products throughout their lifecycle, from concept through end of life, and includes engagement with Notified Bodies and regulatory agencies worldwide. The specialist will develop and execute strategies for new products, modifications, and renewals across the EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other markets. They will author and lead submissions, support post-market compliance and audits, maintain regulatory procedures, and mentor junior team members. Success includes securing and maintaining certifications, obtaining in-country licenses and registrations on time, and maintaining US and international compliance without major audit findings.

Requirements

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, or 3–5 years 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, as well as 510(k) and audit experience.
Ability to independently lead submissions, connect cross-functional teams, and provide clear, practical recommendations.
Must be authorized to work in the U.S. without current or future visa sponsorship.

Nice To Haves

RAC certification.
Clinical study support experience.
Medical device software regulations experience.

Responsibilities

Develop and execute regulatory strategies for new products, modifications, and renewals across EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other markets.
Author and lead Technical Files, Design Dossiers, STED, CE Marking dossiers, change notifications, 510(k)s, and country-specific registrations.
Serve as the main contact with Notified Bodies and global regulatory agencies, including handling inquiries, deficiency responses, and audits.
Provide regulatory input to cross-functional teams throughout the product lifecycle, from concept to end of life.
Support post-market activities, including vigilance, adverse event reporting, and CAPA.
Ensure labeling, UDI, and registrations remain compliant.
Review and approve change requests, protocols, and reports.
Support ISO 13485, MDSAP, and EU MDR audits.
Build and maintain regulatory procedures and mentor junior team members.