Role: Product Surveillance Analyst (Medical Devices)

Location: Minnetonka, MN - 55345

Duration: 12 Months

Shift Timings: 8 AM to 5 PM

Job Description:

Job Duties:

• May perform multiple functions within the post market 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.

Education & Experience:

• 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.
• Years Experience: 0 - 2 years
• Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.

Candidate should have:

• Related experience in post market surveillance in a Medical Device or Pharmaceutical Industry preferred.
• A good candidate will have the skills below
• 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 skills
• 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
• Independent worker/drive/go getter/self starter.
• Strong Data entry skills; Savvy with Microsoft office-Excel, Word, Outlook, PowerPoint and Edge/Chrome and able to demonstrate skill
• Good with Medical Terminology
• Flexibility/willingness to learn and adapt
• Worked in corporate world previously
• Good phone/instant message/email communication
• Self-reliant