Product Surveillance Analyst
5050 Nathan Lane N. Plymouth, Minnesota 55442
Voca has an immediate opening available for a Product Surveillance Analyst in Plymouth, MN! Interested candidates will reach out to Ethan Adler at firstname.lastname@example.org, direct line 303-302-5265.
- 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.
Four-year degree, preferably in the healthcare, science, or technical fields • Knowledge of global regulations for medical device reporting and medical terminology is a plus• Strong written and oral communication skills are required• Good problem-solving and proficient computer skills are required• Ability to work within a team and as an individual contributor in a fast-paced, changing environment• Effectively multitasks, prioritizes and meets timelines• Strong organizational and follow-up skills, as well as attention to detail• Ability to maintain regular and predictable attendance Requires BS degree