Synergy 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 related to medical devices.

Our client has developed the strategy and process required to proactively collect and analyze market and customer feedback on medical devices of which Our client is the legal manufacturer to comply 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 provide 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

· Interface with other functions such as device engineering, medical, safety, regulatory, quality, 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 timely manner to Our client 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, chemistry, or related 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