Post Market Surveillance Coordinator II
Phantom Staffing
Post Market Surveillance Coordinator II
Chelmsford, Massachusetts, United States
Essential Functions:
- Maintain Post Market Surveillance documentation in accordance with procedures and Regulatory requirements to stand on its own in the event of an audit.
- Complete and submit documentation for reportable events to Competent Authorities within required timelines, including but not limited to FDA-3500A MedWatch Reports, Manufacturing Incident Reports for EMEA Vigilance (both MDD and EU MDR), MDPR for Health Canada, etc.
- Coordinate and maintain closure of complaint records in our Post Market Surveillance system.
- Maintain the storage and retrieval of active and inactive complaint records.
- Provide support for Post Market Surveillance activities.
- Support the review and evaluation of customer communications for complaint reporting obligations.
- Communicate and correspond with customers.
Required/Preferred Education and Experience:
- High School required
- 1-3+ years Healthcare or Medical Device Industry preferred
- Regulatory certification exposure to Post Market Surveillance Preferred
- Knowledge, Skills and Abilities
- 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.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Ability to work in collaborative and independent work situations and environments with minimal supervision.
- Attention to detail/Quality work.
- Ability to manage Time effectively.
- Positive attitude/Forward thinker.
- Analytical/ability to take initiative to correct problems.
- Quality or Regulatory experience in Medical Device Experience preferred.
Vacancy posted 2 days ago
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