Regulatory Affairs Associate
Regulatory Affairs Associate
Intellectt Inc
Alameda, CA
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Role: Regulatory Affairs Associate
Location: Alameda, CA - 94502
Duration: 12 Months
Job Description
Location: Alameda, CA - 94502
Duration: 12 Months
Job Description
- Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
- Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports).
- Review/approval of engineering study protocols/reports and validation study protocols/reports.
- Review and approval of manufacturing changes for Class III implantable medical devices.
- May require an advanced degree and 5-8 years of direct experience in the field.
- Recent experience with Class III implantable medical devices;
- Proven successful track record of authoring/submission/approval of Class III implantable PMA supplements;
- knowledge of FDA PMA guidance documents and CFR regulations.
- Relies on extensive experience and judgment to plan and accomplish goals.
- Performs a variety of tasks.
- May lead and direct the work of others.
- A wide degree of creativity and latitude is expected.
- Typically reports to a manager or head of a unit/department
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Staffing and Recruiting
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