Regulatory Affairs Associate

Spectraforce Technologies
United States, Maine, South Portland
Sep 03, 2026
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 Position Summary 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. Key Responsibilities * 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. Qualification & Experience * Technical Diploma (high school or equivalent) * Minimum 1 year experience Additional Information * 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.