Regulatory Affairs Associate

Regulatory Affairs Associate

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.

• 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)