Regulatory Affairs Associate- South Portland, ME Location : South Portland, ME – 04106 Project Duration : 12 Months of contract (Possibility of Extension) Shift Timings : 7:00 AM to 4:30 PM (Mon to Fri) Pay Range : $20.00-22.00 per hour on W2 This is an entry level position regardless of the job description implying a higher level of knowledge/competency. 1 year or less work experience, this will be a lower-level role in Regulatory Affairs in the IVDR group. Main Purpose of the Role: 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. Main 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 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; and Organize meetings with regulatory agency staff. Post market: 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; 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. Education: Technical Diploma (high school or equivalent) Experience: Minimum 1 year experience #J-18808-Ljbffr Generis Tek Inc
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