Regulatory Affairs Associate

Cynet Systems•South Portland, ME

About The Position

Experienced para-professional individual contributor working under limited supervision within the Regulatory Affairs sub-function. Applies subject matter knowledge in the area of Regulatory Affairs. Requires capacity to apply skills/knowledge within the context of specific needs or requirements. Possesses specialized knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

Requirements

Regulatory Affairs
SOP development
Product registration submission
Premarket submissions
Postmarket reports
Chemistry manufacturing control (CMC)
Risk management
Technical labeling

Responsibilities

Assist in SOP development, review and initiation.
Stay abreast of regulatory procedures and changes in regulatory climate and update department.
Investigate regulatory history of similar products to assess approval implications.
Conduct research on submission requirements and options.
Assist in monitoring and reporting project timelines.
Respond to regulatory information requests and monitor and utilize tracking and control systems.
Compile and organize materials for presubmission reports.
Coordinate and assist in the preparation of submission/registration packages.
Coordinate registration requests and track completion.
Implement submission templates.
Oversee quality control of regulatory documents and submissions.
Organize meetings with regulatory agency staff.
Update and maintain global product listings, facility registrations, licenses/approvals, and annual registrations.
Assist in the preparation of routine reports and regulatory agency communications.
Assist in the preparation of postmarket reports and submissions.
Update and maintain paper/electronic document archival systems.
Prepare legal documents for import/export, registrations, tenders/bids or other purposes.
Serve as regulatory liaison throughout product lifecycle.
Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
Ensure timely approval of new medical devices and continued approval of marketed products.
Serve as regulatory representative to marketing and research teams.
Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.