Regulatory Affairs Associate
- Location
- CA-Santa Clara, CA
- Listed
- Today
About the role
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.
From OLSA Resources, Inc.'s careers page, first listed on Rolev.ai on November 12, 2026. Rolev.ai is not the employer.
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Common questions
Where is the Regulatory Affairs Associate job at OLSA Resources, Inc. located?
This Regulatory Affairs Associate position at OLSA Resources, Inc. is located in CA-Santa Clara, CA. Always check OLSA Resources, Inc.'s application page for specific state eligibility or relocation policies.
How do I apply for the Regulatory Affairs Associate position at OLSA Resources, Inc.?
This listing links directly to OLSA Resources, Inc.'s SmartRecruiters application page. You can apply directly on OLSA Resources, Inc.'s site, or use Rolev.ai to check your resume fit, generate a zero-hallucination tailored resume and cover letter for this posting, and autofill the SmartRecruiters application form in 1 click with the Rolev.ai Chrome extension. You always review the form and press Submit yourself.