Job Title: Post Market Surveillance Specialist

Job Description

We are seeking a diligent Post Market Surveillance Specialist to maintain complete complaint files by updating the product report database with new information and documentation from both field personnel and Engineering. This role involves ensuring regulatory and compliance requirements related to the complaint system process are fulfilled. The position requires computer and telephone-based work for extended periods of time in an office environment. Occasional coverage on company holidays may be required.

ResponsibilitiesMaintain complete complaint files by updating the product report database with new information and documentation from both field personnel and Engineering.Communicate effectively with field personnel to ensure complaints are handled efficiently and effectively.Ensure regulatory and compliance requirements related to the complaint system process are fulfilled.Document product and therapy-related field reports within the prescribed timelines and provide any necessary documents required to complete the investigation. Provide follow-up reporting as needed.Complete training requirements and competency confirmations within the required timeline.Comply with applicable quality system procedures/policies and make suggestions for continuous process improvement.Document and evaluate new product reports in accordance with required timelines for escalation, risk, coding, and complaint designation.Facilitate the product return process, disposition products, and ensure return date and disposition status are documented.Lead product report and patient follow-up activities and document the results.Lead investigations as assigned and provide returned product kits to field personnel.Run basic complaint handling reports from the product reporting system.Compile data for regulatory reports as needed.Compose written communications to physicians regarding return receipt and other end-use customers as directed.Train various team members on the complaint handling process and system.Essential SkillsComplaint handlingDocument controlRecord keeping2+ years of experience in complaint or regulatory handlingUnderstanding of FDA/ISO certified environmentKnowledge of medical device terminologySurveillanceDocumentation reviewFDA complianceBiotechnologyComplaint analysisAdditional Skills & QualificationsDocument and evaluate new product reports in accordance with required timelines for escalation, risk, coding, and complaint designation.Facilitate the product return process, disposition products, and ensure return date and disposition status are documented.Lead product report and patient follow-up activities and document the results.Lead investigations as assigned and provide returned product kits to field personnel.Run basic complaint handling reports from the product reporting system.Compile data for regulatory reports as needed.Compose written communications to physicians regarding return receipt and other end-use customers as directed.Train various team members on the complaint handling process and system.Work Environment

The work environment for this role is primarily in an office setting, requiring computer and telephone-based work for extended periods. The position requires availability to work the second shift (1 PM - 9 PM / Noon - 8 PM) and ideally candidates should not have significant travel plans over the holiday season (Thanksgiving and Christmas).

Benefits

medical, dental, vision benefits availableAbout Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.