Description du poste
3M is seeking an Advanced Regulatory Affairs Associate for the Health Care Business Group, Medical Solutions Division, located in Maplewood, MN. At 3M, you can apply your talent in bold ways that matter. Here, you go.
Job Summary :
The person hired for this position will provide regulatory support to marketed device product teams, with focus on hardware and software.
This position provides an opportunity to transition from other private, public, government or military environments to a 3M career.
Primary Responsibilities include but are not limited to the following:
· Providing regulatory support and guidance to assigned device product teams.
· Determining regulatory pathway and provides complete global regulatory assessment of product changes, including submission of 510k packages, as appropriate.
· Providing regulatory support for international registrations and requests for documentation, and support for registration of portfolio products in new markets.
· Review and approval of product labeling and advertising.
· Other duties as assigned.
· Possess a Bachelor’s degree or higher (completed and verified prior to start) from an accredited institution
· Minimum of three (3) years combined device regulatory affairs experience and/or device experience in a private, public, government or military environment
· Bachelor’s degree or higher in a science or engineering discipline from an accredited institution
· Basic understanding of FDA device regulations
· Experience working with medical device hardware and/or software
· Strong written and oral communication skills
· Ability to work effectively in cross functional teams
Location: Maplewood, MN
Travel: May include up to 5%, domestic and international
Relocation: Is not authorized
Must be legally authorized to work in country of employment without a sponsorship for employment visa status (e.e. H1B status).