Regulatory Affairs Manager

San Jose, CA 95134 | Direct

Job ID: 8014 Category: Quality Manager

Qualifications:

  • BS - preferably with courses or training in Regulatory Affairs
  • Experience with international (Chinese/EU) regulations and submissions
  • Must have worked in the medical device industry; 3+ years in a regulatory affairs role
  • Experience submitting to the FDA and OSU (outside of the US)
  • Working familiarity with ISO 13485/14971, MDD 93/42/EEC, 21 CFR 820, Risk Management
  • Labeling Activities: publications, marketing material, medical device safety
  • Previous experience working with R&D team, NPI projects, pre-submissions is desired
  • Ability to manage multiple projects, take initiative to answer questions

Responsibilities:

  • Support and maintain registrations in the US, EU, Asia
  • Support documentation requests, oversee approval process
  • Assist senior management in regulatory activities (e.g. submissions, registrations)
  • Ensure and maintain compliance relevant for Class III medical device
  • Risk management, FMEA meetings, V&V reports
  • Review clinical study documentation
  • Clear communication with international locations
CE, FDA, ISO 13485, ISO 14971, 21 CFR Part 820, invasive device, cardiovascular, medical device, risk management, OUS, MDD 93

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