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.