Regulatory Affairs Associate II (Medical Devices)
Location:
Hybrid (2–3 days onsite) – Lake Forest / San Clemente / San Diego
Duration:
12-month contract (possible extension or conversion to FTE)
Schedule:
8:00 AM – 5:00 PM
Role Summary We are seeking a
Regulatory Affairs Associate II
with hands‑on
medical device regulatory experience
to support U.S. and global submissions. This role supports regulatory strategy execution, preparation of submissions, and maintenance of Technical Documentation to ensure compliance with FDA, EU MDR, and international requirements.
Key Responsibilities
Prepare and manage U.S. and global regulatory submissions (FDA, EU MDR)
Assemble and maintain Technical Files / Technical Documentation
Support change assessments and regulatory impact analyses
Interact with FDA and/or Notified Bodies under supervision
Track submission deliverables and ensure compliance with timelines
Represent Regulatory Affairs in cross-functional project meetings
Required Qualifications
Bachelor’s degree (science or engineering preferred)
2–4 years of Regulatory Affairs experience in medical devices
Hands‑on experience with:
FDA submissions (510(k))
EU MDR (2017/745), GSPR, MDR remediation/compliance
Technical Files / Technical Documentation
ISO 13485
Experience interacting with FDA and/or Notified Bodies
Strong understanding of 21 CFR 820
Excellent communication, documentation, and organizational skills
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Hybrid (2–3 days onsite) – Lake Forest / San Clemente / San Diego
Duration:
12-month contract (possible extension or conversion to FTE)
Schedule:
8:00 AM – 5:00 PM
Role Summary We are seeking a
Regulatory Affairs Associate II
with hands‑on
medical device regulatory experience
to support U.S. and global submissions. This role supports regulatory strategy execution, preparation of submissions, and maintenance of Technical Documentation to ensure compliance with FDA, EU MDR, and international requirements.
Key Responsibilities
Prepare and manage U.S. and global regulatory submissions (FDA, EU MDR)
Assemble and maintain Technical Files / Technical Documentation
Support change assessments and regulatory impact analyses
Interact with FDA and/or Notified Bodies under supervision
Track submission deliverables and ensure compliance with timelines
Represent Regulatory Affairs in cross-functional project meetings
Required Qualifications
Bachelor’s degree (science or engineering preferred)
2–4 years of Regulatory Affairs experience in medical devices
Hands‑on experience with:
FDA submissions (510(k))
EU MDR (2017/745), GSPR, MDR remediation/compliance
Technical Files / Technical Documentation
ISO 13485
Experience interacting with FDA and/or Notified Bodies
Strong understanding of 21 CFR 820
Excellent communication, documentation, and organizational skills
#J-18808-Ljbffr