Regulatory Affairs Associate

generis tek•South Portland, ME

3h•Onsite

About The Position

This is a contract role for a Regulatory Affairs Associate in South Portland, ME, with a duration of 12 months and a possibility of extension. The position is entry-level, despite the description implying higher competency, and requires 1 year or less of work experience. The role involves directing the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports. The associate will assist in SOP development, stay updated on regulatory procedures and changes, investigate regulatory history of similar products, conduct research on submission requirements, monitor project timelines, respond to information requests, and utilize tracking systems. Responsibilities also include compiling and organizing materials for pre-submission reports, coordinating and assisting in the preparation of submission/registration packages, coordinating registration requests, implementing submission templates, overseeing quality control of regulatory documents, and organizing meetings with regulatory agency staff. Post-market duties involve updating global product listings, facility registrations, licenses/approvals, and annual registrations, assisting in routine reports and agency communications, preparing post-market reports, updating document archival systems, preparing legal documents for import/export, and serving as a regulatory liaison throughout the product lifecycle. Participation in product plan development, regulatory strategy, risk management, and CMC may also be required. The role ensures timely approval of new medical devices and continued approval of marketed products, serving as a regulatory representative to marketing and research teams, and advising on manufacturing changes, line extensions, labeling, and regulations.

Requirements

Minimum 1 year experience
Technical Diploma (high school or equivalent)

Nice To Haves

1 year or less work experience
Lower-level role in Regulatory Affairs in the IVDR group.

Responsibilities

Direct development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
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.
Monitor and utilize tracking and control systems.
Compile and organize materials for pre submission 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 post market 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, chemistry manufacturing control (CMC).
Ensure timely approval of new medical devices and continued approval of marketed products.
Serve as regulatory representative to marketing, research teams.
Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.