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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