Regulatory Affairs Associate

Regulatory Affairs AssociateExperienced 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 Level Major/Field of Study or Equivalent Technical Diploma (high school or equivalent)