Biotechnology, Medical Device, Quality/Risk Management
4 Year Degree
Message from the Hiring Manager: 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.
Duties and Responsibilities:
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 Accountabilities:
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
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!
Required Knowledge, Skills and Abilities:
B.S. degree in a biomedical, biotechnology, regulatory sciences, engineering.
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
Desired Knowledge, Skills and Abilities:
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
Hear it from our very own! Learn more about Caldera onGlassdoor
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.
Internal Number: #0491
About Caldera Medical
Caldera Medical is a fast-paced and competitive women’s health, medical device company with a singular mission to improve the quality of life for women.
This mission is the primary driver of our employees who thrive in this competitive industry, all while helping to build a global brand and change the lives of women for the better, not only here, but half way across the world.
We develop and market differentiated surgical implants for use in minimally invasive surgical procedures specifically for the treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse. Our products are used by Urogynecologists, Gynecologists, and Urologists worldwide.
Everything we do as a company is centered around patient care, improving the quality of life for women, and our passion to deliver better outcomes for women who suffer from pelvic floor disorders.