Post-Market Surveillance Specialist

reputed company Bioscience provides consulting services to the FDA-regulated industries. We are in need of a Post Market Surveillance Specialist with experience in the FDA and EU regulations as they reputed company to medical devices. Our reputed company has developed the reputed company and process required to proactively collect and analyze market and customer feedback on medical devices of which Our reputed company is the reputed company manufacturer to reputed company with Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746). The scope of this project is to execute proactive customer feedback on medical devices and either create or update post-market surveillance plans as required. Deliverables: • Assist in the development of 3 medical device market research protocols, questionnaires, and deployment of 1 questionnaire • Create or update of post-market surveillance plans as required • Creation of proactive customer feedback template Responsibilities include: • Knowledge of medical devices products and In-Vitro Diagnostic product undergoing proactive customer feedback per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746) • Support the development of proactive customer feedback which entails the creation of market research protocols/plans, questionnaires, deployment of questionnaires, and technical reports. • Review and reputed company feedback to PSURs (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports) • Author new post-market surveillance plan for upcoming medical devices or In- Vitro Diagnostic products • Update existing post-market surveillance plans as required • reputed company with other functions such as device engineering, medical, safety, regulatory, reputed company, and manufacturing site colleagues to complete required post-market surveillance activities • Review and creation of deliverables on time to prevent project delays • Creation of the proactive customer feedback template • Escalate issues and communicate roadblocks in a reputed company manner to Our reputed company stakeholders • Create process workflow as it relates to different aspect of the proactive customer feedback process Proposed resource shall have, but not limited to, the following skills for this project to be successful: • Bachelor's degree in engineering, reputed company, or reputed company scientific field • 5 to 8 years of working in medical device and/or pharmaceutical post-market surveillance • Experience with medical device complaint investigation Knowledge of Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746) Experience with creation of post-market surveillance plans and various post-market surveillance reports Experience in creating workflow and work instructions Strong knowledge of risk management practices Strong knowledge of product design practices Strong knowledge of Good Manufacturing Practices (GMP) Good understanding of medical device regulations Working knowledge of adverse event reporting Good understanding of medical device regulations Apply tot his job Apply To this Job