Senior Regulatory Affairs Associate BG Medicine

General Summary:

A senior-level position in Regulatory Affairs, under management of Regulatory Affairs Senior Management, this position participates in all aspects of regulatory affairs for BG Medicines medical device business. Candidate works with QA, Product Development, Technical Services, other groups and interfaces with a variety of external parties, including FDA and BGMs Authorized Representative.

Duties and Responsibilities:

Organizes, compiles and manages the preparation and assembly of regulatory submissions. Creates and maintains paper and electronic submission files, with tracking of revisions.
Primary responsibility for accurately completing all regulatory sections of submissions, including but not limited to 510(k) Summaries, MDUFA, coversheet, checklists, etc.
With Sr. Regulatory professional(s), contributes to the development of regulatory submission strategies on behalf of new product approval/clearance, claim extensions or modifications.
Reviews and modifies labeling and DCOs for compliance to applicable regulatory requirements. Conducts assessments for device and label modifications and prepares Notes-to-File per regulatory guidance and company procedures.
Manages relationship with European Authorized Representative and completes reports and updates on behalf of BGMs EU devices, as needed. Manage GMDN process.
Manage label development process (pre-market only).
Reviews reportable complaints and assists QA and Medical Affairs with the preparation of MDR and/or Vigilance Reports.
Maintain FDA Listings for all applicable BGM devices.
Other duties as defined by manager.



Minimum Education & Experience:

Bachelors-level degree required. Degree in science/health related field (e.g.,

Biology, Chemistry, Biomedical, Medical Technology) preferred. 5-10 years experience in

FDA-regulated industry required; Minimum 2 years in medical devices required.



Working Conditions:

General office environment with some flexibility in hours.



Competency Expectations:

Knowledgeable of the laws, regulations, standards and guidance governing medical devices in the US, EU, Canada and other markets.
Experience with In Vitro Diagnostic devices (IVD) highly desirable.
Good verbal and written communication skills.
Excellent interpersonal and organizational skills.
Detail oriented and good problem solving ability.
Ability to work with internal and external partners and with multiple projects.
Working knowledge of medical terminology required.
Excellent computer skills (experience with spreadsheets and word processing programs).
Project coordination experience preferred.
Independently motivated.

Location:	610 North Lincoln Street Waltham, MA 02451 United States