Sr. Regulatory Affairs Specialist

Job Description

Job Description

Sr. Regulatory Affairs Specialist

Location: 100% On-site | Caldera HQ, Westlake Village, CA

Caldera Medical’s Mission - To Improve the Quality of Life for Women!

About Caldera Medical
Caldera Medical is committed to improving the quality of life for women worldwide through innovative pelvic health and neuromodulation solutions. Headquartered in Westlake Village, CA, with international operations in Neuchâtel, Switzerland, Caldera combines clinical insight with engineering excellence to bring meaningful therapies to market.

Message from the Hiring Manager
This 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

Our Culture- Where Career and Passion come together!

• A culture of family and team… not a corporate goliath where you're just another number.
• All employees get a seat at the table and have influence with management. We care about giving back to the community. Our team donates time to helping local charities throughout Southern California.
• The Women's Health Initiative is the heart of what we do; every day we put underprivileged women first.
• Our goal is to treat 1 million women suffering from incontinence by 2027!

Why This Role Matters
Every approval you secure brings treatment to more women. That includes our goal of treating 1 million underserved women suffering from incontinence by 2027. At Caldera, your work is visible and it makes a real difference.

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.)

Who is Caldera Medical?
Caldera Medical is dedicated to improving the quality of life for women through innovative surgical solutions for stress urinary incontinence, pelvic organ prolapse, polyps, and fibroids.

Our products are trusted by surgeons worldwide, and our commitment extends beyond medical advancements. We foster strong partnerships with surgeons and lead the largest humanitarian program in women’s health, aiming to provide treatment to one million underserved women by 2027.

Guided by integrity, we prioritize patients, customers, employees, and the community over profit. As the fastest-growing women’s health company, we remain committed to expanding education and access to life-changing care for women everywhere.

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.