Cardiovascular Specialty Solutions Group (CSS) Group, a Family of Companies within Johnson & Johnson, is recruiting for a Senior Regulatory Affairs Specialist, located in Irvine, CA.
Cardiovascular Specialty Solutions Group (CSS) Group is combining ASP, Acclarent, Biosense Webster and Mentor into a single business unit, single global management board, single P&L.
One geographic Medical Device hub in Irvine will allow for critical mass and geographic efficiencies, including an enhanced ability to attract and develop talent and drive product portfolio to accelerate innovation.
Acclarent, Inc. is a medical device company, whose singular focus is to free patients to live better lives by designing, developing, and commercializing medical devices that address conditions affecting the ear, nose, and throat.
Advanced Sterilization Products (ASP) truly makes a difference by Protecting Lives against Infection®. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions.
Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders and one of the fastest-growing businesses within Johnson & Johnson.
Mentor Worldwide LLC is a leading supplier of medical products for the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow patients to improve their quality of life through breast, body and facial aesthetics.
This position is specific to Advanced Sterilization Products (ASP)
- Writes, coordinates, compiles, and submits Regulatory documents to FDA and other Regulatory Agencies, including EPA and International Authorities. Also includes the preparation of international documents, including Technical Files.
- Works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products. Creates detailed Regulatory Plans. Includes in-depth team involvement, including Core Team membership for complex projects
- Evaluates proposed product modifications for Regulatory impact on a world-wide basis. Completes Regulatory Assessments as needed.
- Ensures compliance with regulatory agency regulations and interpretations.
- Ensures preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Prepares responses to regulatory agencies’ questions and other correspondence.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Develops timelines for submissions under the direction of senior regulatory affairs staff.
- Provides solutions to extreme complex problems.
- Provides regulatory advice to project teams.
- A minimum of a Bachelor’s Degree is required, advanced degree preferred
- A focused degree in a scientific discipline or regulatory affairs is preferred
- 3+ years of medical device regulatory affairs experience is required
- Experience writing 510(k)’s is preferred
- Experience with EU technical files is preferred
- Quality systems experience is a plus.
This position is located in Irvine, CA and may require up to 10% domestic travel.
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Advanced Sterilization Products (ASP)Job Function