Job Description
Position : Regulatory Affairs Associate
Location: Santa Clara,CA (Onsite)
Duration: 12 months
Job Description:
Key Responsibilities:
- Prepare and submit PMA supplements for Class III medical devices.
- Review and approve engineering and validation study protocols and reports.
- Evaluate and support manufacturing changes requiring regulatory oversight.
- Interpret and apply FDA regulations and guidance related to PMA submissions.
- Serve as a key regulatory partner for internal teams, offering strategic input and compliance leadership.
Qualifications:
- 5 8 years of direct regulatory affairs experience, ideally within Class III implantable medical devices.
- Demonstrated success in authoring, submitting, and gaining approval of PMA supplements.
- Deep knowledge of FDA,ISO 13485, 21 CFR Part 820 regulations and PMA guidance.
- Advanced degree preferred (MS, PhD, or equivalent experience).
- Strategic thinker with a strong ability to manage multiple priorities and deadlines.
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