Post Market Surveillance Coordinator II

Phantom Staffing; Chelmsford (MA); On-site; USD 50,000 - 70,000; Full time

Job summary

A staffing agency is seeking a Post Market Surveillance Coordinator II to maintain documentation and ensure compliance with regulatory requirements. The role involves completing and submitting reportable event documentation, coordinating complaint records, and supporting other Post Market Surveillance activities. Candidates should have at least a High School diploma with 1-3 years of relevant experience in the Healthcare or Medical Device industry. Strong communication skills and attention to detail are essential for success in this role.

Qualifications

• 1-3+ years experience in Healthcare or Medical Device Industry preferred.
• Regulatory certification exposure to Post Market Surveillance preferred.
• 2-5 years experience in an FDA and ISO regulated environment preferred.

Responsibilities

• Maintain Post Market Surveillance documentation in accordance with procedures.
• Complete and submit documentation for reportable events to Competent Authorities.
• Coordinate and maintain closure of complaint records in the Post Market Surveillance system.

Skills

Knowledge of FDA QSR, 803, MDD, MDR, ISO13458 and MDSAP

Strong verbal and written communication skills

Ability to manage time effectively

Analytical skills

Education

High School diploma

Job description

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.