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Product Surveillance Analyst

Company:
ATR International
Location:
Plano, Texas, 75024, United States
Posted:
July 16, 2018
Description:

Job Title: Analyst, Product Surveillance II

Job Location: Plano, TX

Job Duration: 11 months

Job Description:

We are seeking an Analyst - Product Surveillance for a very important client.

Duties:

- 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.

Analyst may perform two different functions within complaint handling. One role is that of complaint investigation management which includes all activities pertaining to receiving and investigating reports of worldwide complaints/events on a variety of products; entering information into the complaint database; independently determining and filing appropriate medical devices reports with various regulatory agencies; participating on cross-functional teams; and providing information on product complaints to various teams (e.g. Regulatory, Quality Engineering).

Requirement:

The ideal candidate will possess the following skills:

- Must have excellent computer skills (Outlook, MS Office, especially Excel) and the ability to effectively communicate, in English, both verbally and in the written form.

- The position is very fast-paced so the candidate must be very organized with the ability to multi-task.

- Candidate should be able to maintain regular, predictable attendance.

- Relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work.

- Knowledge of global regulations for medical device reporting and medical terminology is a plus.

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, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work.

- Degreed applicants without medical, scientific, or complaint handling experience may be considered if they possess the strengths suitable for this position.

Additional info:

Must have excellent computer skills (Outlook, MS Office, especially Excel) and the ability to effectively communicate, in English, both verbally and in the written form. The position is very fast-paced so the candidate must be very organized with the ability to multi-task. Candidate should be able to maintain regular, predictable attendance. Skills: relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work. Knowledge of global regulations for medical device reporting and medical terminology is a plus Education: Four-year degree, preferably in the healthcare, science, or technical fields; or 2-year degree and 10 years of relevant experience supporting complaint handling investigations, medical device reporting, product evaluation, or related work