Job Title: Regulatory Affairs Associate
Location: South Portland, ME
Duration: 12 months, with possible extension
Shift: 7:30 AM to 4:30 PM
MAIN PURPOSE OF THE ROLE
Experienced paraprofessional individual contributor working under limited supervision within the Regulatory Affairs sub-function.
Applies subject-matter knowledge in Regulatory Affairs.
Requires the capacity to apply skills/knowledge within the context of specific needs or requirements.
MAIN RESPONSIBILITIES
" As the experienced paraprofessional in the Regulatory Affairs Sub-Function, possesses specialized knowledge in directing the development of product registration submissions, 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 the regulatory climate and update the 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 the 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 and research teams.
" Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations, and interpretations.
Education:
Education Level
Major/Field of Study
or
Equivalent
Technical Diploma (high school or equivalent)