Post Market Surveillance Coordinator II
Post Market Surveillance Coordinator II
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 FDA3500A 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
13 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. 25 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.
Employment Type
Full Time
