Regulatory Affairs Associate

Position Title: Regulatory Affairs Associate

Work Location: South Portland, ME 04106

Assignment Duration: 12 Months (Possibility of Extension)

Work Schedule: 7:00 AM - 4:30 PM, Monday - Friday

Work Arrangement: Onsite

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.

* As the Experienced para-professional in the Regulatory Affairs Sub-Function, possesses specialized knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.

* Strategic Planning: 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.

* Premarket: 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; and Organize meetings with regulatory agency staff.

* Postmarket: 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.

* Serves as regulatory liaison throughout product lifecycle.

* Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).

* Ensures timely approval of new medical devices and continued approval of marketed products.

* Serves as regulatory representative to marketing, research teams.

* Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.

* Technical Diploma (high school or equivalent)

* Minimum 1 year experience

* This is an entry level position regardless of the job description implying a higher level of knowledge/competency.

* +/- 1 year work experience.

* Lower-level role in Regulatory Affairs supporting the IVDR group.

* Approved for one year from the start date with possibility of extension.