Analyst, Product Surveillance
3 weeks ago
Analyst, Product Surveillance
North Plymouth MN United States
12-month contract with high possibility of extension
Pay rate: $24/hr.
Job description:
Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.
Strong analytical and investigative skills.
Familiarity with complaint handling investigations, medical device reporting, or product analysis.
Attention to detail and ability to make critical decisions.
Excellent communication skills, both verbal and written.
Education:
Four-year degree, preferably in the healthcare or science fields; or
2-year degree and relevant experience supporting complaint handling investigations, medical device reporting, or product analysis.
Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess suitable strengths for the position.
Duties:
Perform multiple functions within the postmarket surveillance department.
Determine classification, review, and disposition of adverse events and medically related complaints for on-market products.
Make decisions on the seriousness, reportability, and potential causality of adverse events.
Complete FDA Medical Device Reporting (MDR) and other regulatory reports required by outside competent authorities.
Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
Maintain accurate documentation and records related to postmarket surveillance activities.
Stay updated on regulatory changes and industry trends affecting postmarket surveillance.
Participate in internal and external audits as needed.
Contribute to process improvement initiatives within the postmarket surveillance department.
We are looking for the candidate who are eligible to work with any employers without sponsorship.
If you’re interested, please click “Apply” button.
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