The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Manager, Regulatory Affairs, aligned to Sterilmed. The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
As an FDA-registered medical device manufacturer, Sterilmed provides an affordable solution for hospitals faced with the challenge of reducing costs without compromising patient care. We are proud to be a part of keeping healthcare accessible and affordable for all by delivering deep, sustained savings for our reprocessing customers.
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 and supporting international registration activity as needed. Will provide 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.
Plans, develops and applies regulatory strategies that permit the successful pre-market submissions of products worldwide
Identifies, develops, implements, and maintains innovative processes that promote efficiency change control and for worldwide registrations
Reviews and analyzes ECRS, NCs, manufacturing changes, 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
Participate and provide regulatory guidance and support to cross-functional teams
The position will require interaction with the US.FDA, and with other regulatory authorities around the world
This position will include participation on New Product Development (NPD) teams to provide regulatory guidance and to obtain rapid and timely clearance of new products.
Review and analyze technical data generated by Research and Development, Marketing/Sales, Quality Assurance and other related departments
Evaluate changes in regulatory environment and standards
Conduct gap analysis and implementation plans to assure compliance to latest requirements
- A Bachelor's degree and a minimum of 5 years of regulatory affairs experience in the medical device space is required
- An advanced degree / RAC is desirable
- Successful experience taking a product through the development and regulatory cycle domestically is required, internationally is a plus
- Experience with multi-site organization is preferred
- Global regulatory affairs and compliance experience is desired
- Proven leadership and project management skills are desired
- A successful track record coordinating and interacting with multiple cross-functional teams is desired
- Experience working with professional and trade associations is a plus
- Travel may require up to 10% international and domestic travel, as needed
This position is based in Plymouth, MN. It is preferred that the incumbent is based in Plymouth; however, consideration will be given to remote candidates provided they can travel to Plymouth at least 50% of the time.
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United States-Minnesota-PlymouthOther Locations
North America-United StatesOrganization
Sterilmed, Inc. (6215)Job Function
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