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 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. #J-18808-Ljbffr