Regulatory Affairs Specialists

01

Coordinate efforts associated with the preparation of regulatory documents or submissions.

02

Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.

03

Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.

04

Coordinate, prepare, or review regulatory submissions for domestic or international projects.

05

Prepare or maintain technical files as necessary to obtain and sustain product approval.

06

Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

07

Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling changes.

08

Coordinate recall or market withdrawal activities as necessary.

09

Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.

10

Review adverse drug reactions and file all related reports in accordance with regulatory agency guidelines.