- Title: Regulatory Affairs Associate Jr
- Code: RCI-5401
- Location: Santa Clara California (CA) 95054
- Posted Date: 09/25/2020
- Duration: 12 Months
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- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
- Responsible for filing necessary applications and handling global regulatory submissions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting 510k or PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Experienced with CE and International product registration/submission.
- Review/approval of engineering study protocols/reports and validation study protocols/reports.
- Review and approval of manufacturing changes for Class III medical devices.
- May require an advanced degree and 5-8 years of direct experience in the field.
- Recent experience with Class II and/or Class III medical devices;
- Proven successful track record of authoring/submission/approval of Class III PMA supplements or 510k clearance; knowledge of US FDA guidance documents and EU MDR regulation.
- Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- A wide degree of creativity and latitude is expected. Typically reports to a manager or head of a unit/department.
0-2 years experience in a medical device regulated industry Skills: Ability to schedule and organize multiple projects
Education: BS Engineering or Science/Medical
- Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams.
- Manage regulatory submissions and ensure timely regulatory approval of medical devices.
- Ensure all client product and procedures comply with applicable regulatory agency requirements and guidelines.