Post Market Surveillance Coordinator II
On-siteChelmsford, Massachusetts, United States
Job Summary
Maintain Post Market Surveillance documentation in accordance with procedures and regulatory requirements to stand on its own during audits. Complete and submit documentation for reportable events to Competent Authorities within required timelines, including FDA-3500A MedWatch Reports, Manufacturing Incident Reports for EMEA Vigilance, and MDPR for Health Canada. Coordinate and maintain closure of complaint records and support the review of customer communications for reporting obligations. Communicate and correspond with customers while managing time effectively in a collaborative environment. This role supports Post Market Surveillance activities within the Medical Device industry, requiring familiarity with FDA QSR, 803, MDD, MDR, ISO13485, and MDSAP.
Required Qualifications
- High School required
Desired Qualifications
- 1-3+ years Healthcare or Medical Device Industry preferred
- Regulatory certification exposure to Post Market Surveillance Preferred
- Has Knowledge of FDA QSR, 803, MDD, MDR, ISO13458 and MDSAP is preferred
- 2-5 years experience in an FDA and ISO regulated environment preferred
- Quality or Regulatory experience in Medical Device Experience preferred
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