Regulatory Postmarket Specialist

Job description

Primary Function of Position This role provides expertise and support for developing post-market strategies, plans, and reports for new and existing products. Collaborates with cross-functional teams to create documentation such as PMS Plans and Periodic Safety Update Reports (PSURs) that support regulatory approvals and ensure compliance. Partners closely with Regulatory Affairs, Quality, Risk Management, Medical Science, Clinical Affairs, and Medical Affairs.

Essential Job Duties

Support the development of strategies that meet regulatory post-market requirements in collaboration with cross-functional teams. Create regulatory post-market documentation such as PMS Reports and PSURs. Summarize data and use methods of data presentation that improve the quality and readability of reports and documentation. Build relationships with key stakeholders and cross-functional partners including Regulatory Affairs, Post Market Surveillance, Quality Assurance, Risk Management, Medical Science, Clinical Affairs and Medical Affairs.

Apply working knowledge of regulations like European Union Medical Device Regulation (MDR) to guide project teams through the regulatory post market requirements. Demonstrate good judgement for obtaining solutions. Work to manage priorities and drive results with some supervision. Facilitate effective team collaboration by leading meetings, using software tools (e.g. Zoom, Box, SharePoint), and developing dashboards and other communication tools.

Draft and assemble documentation as required for internal records and regulatory submissions. File documentation in systems such as Agile. Participate in process improvement activities to continuously improve process effectiveness. Execute on projects as required by Manager or Director of Post Market.

Qualifications

Required Experience and Education

Degree in engineering, life science, or equivalent (S.T.E.M.) with minimum of 5 years of related experience Advanced English proficiency, both written and spoken. Required Knowledge, Skills and Abilities Knowledge of data analysis and technical writing. Understanding of Medical Device Complaint files and quality record documentation. Understanding or experience of Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDR requirements, etc.).

Working technical and clinical medical device knowledge.