Post Market Surveillance Coordinator

Post Market Surveillance Coordinator A&A Search Staffing - 3.5 Lowell, MA Job Details Contract From $29 an hour 1 day ago Qualifications Customer communication Regulatory reporting GMP High school diploma or GED FDA regulations Full Job Description This role is part of the company's Post Market Surveillance and Regulatory reporting program. Our Regulatory program is designed to meet FDA's Quality System Regulation (QSR/Good Manufacturing Practices (GMP) MDD, EU MDR, MDSAP and the globally harmonized standard

ISO 13485.

This person will be instrumental in meeting Post Market Surveillance obligations surrounding submissions involving devices. There will be interdepartmental interactions involving Quality Assurance, Compliance, Technical Support, Service and Regulatory Affairs surrounding Post Market Surveillance activity. There will be opportunities to showcase talents in an effort to continuously improve, develop, and foster growth.

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.

Job Type:

Contract Pay:

From $29.00 per hour

Work Location:

Hybrid remote in Lowell, MA 01850