Post-Market Vigilance 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

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.