Cardiovascular Specialty Solutions Group (CSS) Group, a Family of Companies within Johnson & Johnson, is recruiting for a Regulatory Affairs Specialist III – International Markets, 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).
The Regulatory Affairs Specialist III – International Markets provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Under minimal supervision, the individual leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. The RA Specialist III helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. The role assists in the development of best practices for Regulatory Affairs processes.
POSITION DUTIES & RESPONSIBILITIES:
- Ensures compliance with regulatory agency regulations and interpretations.
- Prepares responses to regulatory agencies' questions and other correspondence.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Provides solutions to a variety of problems of moderate scope and complexity.
- Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
- Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance
- Provides regulatory guidance to product development teams and responds to product information requests
- Provide Regulatory Affairs support during internal and external audits
- Assists in the development of best practices for Regulatory Affairs processes
- Represents Regulatory Affairs on cross-functional project teams.
- Responsible for USA Establishment registration at FDA and product listing.
- Provide regulatory support to Tender requests from affiliates.
- Submission of CFG/CFS applications at health authorities
- A minimum of a Bachelor’s degree is required. A focused degree in science, biomedical engineering, medical / scientific writing, or public health administration is preferred.
- 4+ years of regulatory affairs or related/equivalent experience in a regulated industry (pharmaceutical, medical device, OTC, and/or consumer products) is required
- International regulatory experience in medical devices is desirable
- RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, is desirable
This position is based in Irvine, CA
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Advanced Sterilization Products (ASP)Job Function