Regulatory Affairs Associate
$15.53 - $20.53 per hourCynet Systems
Job Overview:
Pay Range: $15.53hr - $20.53hr
Requirement/Must Have:
Pay Range: $15.53hr - $20.53hr
Requirement/Must Have:
- 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.
- Possesses specialized knowledge in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
- 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.
- 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.
- Organize meetings with regulatory agency staff.
- 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.
- Serve as regulatory liaison throughout product lifecycle.
- Participate in product plan development and implementation, regulatory strategy, risk management, and chemistry manufacturing control (CMC).
- Ensure timely approval of new medical devices and continued approval of marketed products.
- Serve as regulatory representative to marketing and research teams.
- Advise development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
- Regulatory Affairs.
- SOP development.
- Product registration submission.
- Premarket submissions.
- Postmarket reports.
- Chemistry manufacturing control (CMC).
- Risk management.
- Technical labeling.
Vacancy posted 10 hours ago
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