Director of Regulatory Affairs

ONSITE in Westlake Village, CA

Message from the Hiring Manager:

The Director of Regulatory Affairs will lead global regulatory strategy, manage submissions, obtain necessary licenses and approvals, and ensure compliance with U.S. and international regulations including FDA, EU MDR/MDD, MDSAP, NMPA, TGA, and other global regulatory bodies. This strategic role includes oversight of regulatory activities across the product lifecycle, supporting innovation, market access, and post-market compliance. This individual will report directly to executive leadership and play a critical role in shaping regulatory strategy for growth and global expansion.

Duties and Responsibilities:

• Define and execute global regulatory strategies for Class I, II and III medical devices across all stages of the product lifecycle.
• Lead the development and execution of regulatory submissions such as 510(k), PMA, EU MDR Technical Files, and global market registrations, ensuring successful licensing and compliance.
• Serve as primary liaison with global regulatory authorities, including FDA, EU Notified Bodies, NMPA, and TGA, managing communications and negotiations.
• Monitor and interpret evolving global regulatory requirements and integrate into internal processes.
• Collaborate with R&D, Quality, Clinical, and Marketing teams to align regulatory strategy with business objectives.
• Serve as regulatory SME during audits and inspections (FDA, Notified Body, MDSAP).
• Lead post market regulatory activities including labeling, promotional review, vigilance, and complaint management.
• Support regulatory due diligence for mergers and acquisitions.
• Build, mentor, and lead a high-performing regulatory affairs team.
• Represent the company in regulatory advocacy, policy development, and industry associations.

Required Knowledge, Skills and Abilities:

• Bachelor’s degree in engineering, life sciences, regulatory affairs, business or related field.
• 10+ years of progressive experience in regulatory affairs within the medical device industry.
• Proven track record with global submissions and approvals for Class I, II and III devices.
• In-depth knowledge of FDA, EU MDR/MDD, MDSAP, NMPA, and ISO 13485.
• Demonstrated leadership in managing regulatory teams and projects in a global environment.
• Excellent communication, cross-functional collaboration, and strategic leadership skills.

Travel:

• Up to 15% domestic and international travel may be required.

Competitive Compensation, Comprehensive Benefits, and more!

• $150K-176K Annual Salary
• Medical and Dental Benefits – 75% paid for employee and family members
• 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- including your birthday!
• Being surrounded by amazing people!

(This role is being filled internally, and we are not engaging external agencies at this time.)

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!

Who is Caldera Medical?

Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. In 2018, Caldera was ranked one of Inc 5000’s fastest growing private companies in the United States and was ranked #38 fastest growing private company and #3 fastest growing Healthcare Company in Los Angeles by the LA Business Journal. We develop and market differentiated surgical implants specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.

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.