Voca Professional has immediate openings available for Product Surveillance Analyst professionals in Plano, TX!
Voca connects healthcare professionals with fantastic health systems nationwide. Our goal is full partnership with our employees, providing the tools, guidance, and opportunities to help reach their individual goals. Voca provides benefits including insurance, 401k, and dedicated support!
Assignment details are provided below, we’re very excited to hear from you!
- May perform multiple functions within the postmarket surveillance department.
- Major responsibilities would include determining classification, review, and disposition of adverse events and medically related complaints for on-market products, including decisions on seriousness, reportability, and potential causality.
- Complete FDA MDR and other outside competent authority regulatory reports.
- Years Experience: 3 - 5 years
- Skills: Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry.
- At least one year of experience with MDR and OUS regulatory reporting experience required.
- Knowledge of the use, development, and regulatory environment of medical devices.
- Knowledge of 21 CFR Part 820, 198, Complaint Files, and 21 CFR Part 803, Medical Device Reporting.
- 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 the strengths suitable for this position.
Partnering with Voca comes with a number of benefits including:
- Dedicated Recruiter
- Competitive, Flexible Pay Packages
Voca: The Spirit of Work