Regulatory Affairs Associate ∞ (Maplewood, MN)

Job description

Description du poste

3M is seeking a Regulatory Affairs Associate for the Health Care Business Group (HCBG)  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 the position of Regulatory Affairs Associate will focus on global commercialization of new products for the Health Care Business Group.

For additional business group/division/product information, please visit: https://www.3m.com/3M/en_US/health-care-us/

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, strategy and guidance for new medical products which may include devices, drugs and/or biologics (on product development teams)
·  Determining regulatory pathway and provide complete global regulatory assessment of novel product introductions, including submission of pertinent global regulatory submissions, as appropriate
·  Coordinating the preparation of US and global regulatory submissions for products (device, drug and/or biologics)
·  Inputting into requirements for medical product labeling, claims, advertising, and approve final versions
·  Supporting international registrations of new products

Basic Qualifications:

·  Possess a Bachelor’s degree or higher in a Science or Engineering discipline (completed and verified prior to start) from an accredited institution
·  Minimum two (2) years of regulated medical product (device, drug, biologic) experience working in regulatory affairs, laboratory and/or quality (private, public, government or military)

Preferred Qualifications:

·  Master’s degree or higher from an accredited institution
·  Minimum six (6) years of regulated medical product (device, drug, biologic) experience working in regulatory affairs, laboratory and/or quality (private, public, government or military)
·  Direct, first-hand experience leading both U.S. and Global registration of novel medical products including devices, drugs and/or biologics
·  Broad medical product regulatory experience including devices, drugs and/or biologics
·  Understanding of medical device regulations and/or quality systems
·  Experience in medical product design and/or support
·  Experience with global medical product registration
·  Detail oriented, ability to navigate matrix environment
·  Strong communications skills (oral, written and presentation)
·  Experience working on a global cross-functional team
·  Microsoft Office proficient

Location: Maplewood, MN

Travel: May include up to 5% domestic

Relocation: Is not authorized

                                                 

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).