Proclinical is currently recruiting for a Post-Market Surveillance Engineer with a pharmaceutical company located in Chicago, IL. The candidate will support technical investigational review activities for device and combination products in support of the Post Market Surveillance Program.
- Support the implementation of a Post Market Surveillance Program into the Quality Management System.
- Participates in periodic reviews related to clinical and commercial device and combination product investigation outcomes.
- Partner with risk management to ensure Post Market Surveillance requirements are met.
- Perform data analytics on the global complaint data in order to support trend analysis and determine further actions or ad-hoc risk assessments to be performed.
Skills and Requirements:
- Bachelor's Degree, in Sciences or Engineering (Biomedical, Mechanical)
- Minimum of 3 years of experience in medical devices or related industry with a concentration in Post Market Surveillance, Global Combination Product Relations, reliability and risk assessment.
- Previous working experience in a medical device manufacturing environment desired.
- Knowledge of the regulatory and compliance requirements of device design controls and combination products ( i.e. FDA QSR 21 CFR Part 4 and 820 / ISO13485 quality system requirements).
If you are having difficulty in applying or if you have any questions, please contact Brianna Copeland at 617-830-7546.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.