Post Market Surveillance Coordinator II

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.