Senior Regulatory Affairs Specialist Role
Caldera Medical's Mission - To Improve the Quality of Life for Women!
Message from the Hiring
The Sr. Regulatory Affairs Specialist is involved with developing regulatory strategies and tactics for new and existing medical devices. The ideal candidate would possess the skills to coordinate, maintain and provide compliance with applicable domestic and international regulatory agencies, such as the FDA. The position is on-site at our Agoura Hills location and may require travel as necessary to complete time-sensitive projects.
- Plan, prepare, coordinate, track, follow-up, provide guidance, manage and obtain clearances, registrations and submissions for medical device submissions in US and OUS.
- Work with project teams through all phases of product development and provide Regulatory Strategy.
- Work with project teams and responsible leaders to provide compliance/requirements for products, processes and procedures.
- Represent Regulatory in Quality Management System implementation and updates.
- Participate in the planning, conduct, and reporting for external audits as requested.
- Remain current on developments in field(s) of expertise, regulatory requirements and industry trends. Monitor impact of changing regulations on submission strategies and provide interpretation and strategy on compliance.
Objectives and Measurable Performance
- Authoring PMA annual report, supplements, amendments
- Authoring/Supporting 510(k) submission, responses, memos to file
- Researching applicable standards and applications to product, processes, etc.
- Supporting international product registrations, such as CE or CMDCAS
Desired Knowledge, Skills and
- Certifications with RAPS, ASQ, CQE preferred
- International regulatory affairs experience
- Excellent interpersonal and communication skills
- Strong project planning and organizational skills
- Ability to prioritize effectively, ability to ensure all projects are completed in an effective and timely manner
- Possess strong work ethic; think independently, and problem solve,
- Self motivated with a desire to take initiative and look for ways to improve processes and create efficiencies;
- Exceptional follow-through and attention to detail
- Extremely flexible, highly organized and able to shift priorities
- Proficient in MS Office
Required Knowledge, Skills and
- 3 years' experience in US Regulatory Affairs in the Medical Device industry.
- 2 years' experience working for a company with less than $50 million in revenue
- Experience with Class II (and above) medical devices
Who is Caldera Medical?
Caldera Medical is a growth stage medical device company dedicated to improving the quality of life for women. 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's leadership team lives the core values it believes. It's great to see true leaders set the tone for their employees by teaching them how to be happy individuals.“
- Jose Charvet, Sr. Mechanical Engineer
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 2025!
Competitive Compensation, Comprehensive Benefits, and more!
- 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!
Hear it from our very own! Learn more about Caldera on Glassdoor
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.