Sterilmed, a member of Johnson & Johnson's Family of Companies is recruiting for a Manager, Regulatory Affairs for the Central Region.
As an FDA-registered medical device manufacturer, we provide 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
Functional and Technical Competencies:
· Successful experience taking a product through the development and regulatory cycle domestically is required
· Excellent oral and written communication skills are required
· Successful experience taking a product through the development and regulatory cycle internationally is preferred
· Experience with multi-site organization is preferred
· Global regulatory affairs and compliance experience is desired
· Direct experience with global regulatory submissions is desired
· Proven leadership and project management skills are desired
· A successful track record coordinating and interacting with multiple cross-functional teams is desired
· Travel may require up to 10% international and domestic travel, as needed
Sterilmed is willing to consider candidates who are able to relocate to the Minneapolis, Maple Grove or near the Plymouth metropolitan area and work onsite at Sterilmed location.
This position will be located in Plymouth, MN and may require travel both domestic and international locations.
· A Bachelor's degree and a minimum of 5 years of regulatory affairs experience in the medical device space is required
· A Bachelor's degree in a scientific discipline and an advanced degree / RAC is desirable
· Experience working with professional and trade associations is a plus