Job Openings Post Market Surveillance Coordinator II

About the job Post Market Surveillance Coordinator II

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.