Cardiovascular Specialty Solutions Group (CSS) Group, a Family of Companies within Johnson & Johnson, is recruiting for a Manager of Regulatory Affairs, 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.
CA Companies that make up CSS:
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 Mentor Worldwide, LLC.
The Manager, Regulatory Affairs will be responsible for managing projects related to meeting Regulatory Affairs requirements on a worldwide basis. S/he will be responsible for the preparation and submission of 510(k)s, PMAs, PMA Supplements, IDEs, Design Dossiers/Technical Files and Change Notifications for CE Marking.
•Identifies plans, develops and applies regulatory strategies that permit the successful pre-market submissions of products worldwide.
•Identifies, develops, and implements innovative processes that promote efficiency for worldwide registrations.
•Reviews and analyzes ECOS, NCRs, manufacturing changes, clinical, design, and manufacturing protocols and documents.
•Manage lifecycle management activities such as CAPAs, labeling, audit preparation and support, promotional and advertising review, technical file/design dossier updates.
•Organize project teams, initiates project schedule documentation and provides project leadership on a worldwide basis in order to achieve desired outcomes within timeframes defined.
•Participate and provide regulatory guidance and support to senior management and cross-functional teams.
•The position will require interaction with the US.FDA, and to other regulatory authorities around the word.
•This position will include participation on New Product Development (NPD) teams to provide regulatory guidance and to obtain rapid and timely approval of new products.
•Review and analyze technical data generated by Research and Development, Marketing/Sales, Clinical Research, Quality Assurance and other related departments.
•Evaluate changes in regulatory environment and standard. Conduct gap analysis and implementation plans to assure compliance to latest requirements.
•A Bachelor's degree and a minimum of 5years of experience in regulatory affairs is required.
•A Bachelor's degree is a scientific discipline and an advanced degree / RAC is desirable.
•Global regulatory affairs and compliance experience is required.
•Direct experience with global regulatory submissions is required.
•Proven leadership and project management skills are desirable.
•Experience with multi-site organization is preferred.
•A successful track record coordinating and interacting with multiple cross-functional teams is desired.
•Successful experience taking a product through the development and regulatory cycle both domestically and internationally is desired.
•Excellent oral and written communication skills are required.
•Up to approximately 25% international and domestic travel may be required.
•This position will be located in Irvine, CA and may require travel both domestic and international.
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