Pay: $30-35/hr
Location: Must be located in the MN
Job DescriptionWe 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.Skills & Qualifications2+ yeas of experience in complaint or regulatory handlingUnderstanding of FDA/ISO certified environmentKnowledge of medical device terminologyAbout ActalentActalent 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 & InclusionAt 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 peopleThe 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.