Philips Clinical Operations Specialist EU MDR (m/f/d) in Hamburg, Germany


Job Summary

The Clinical Operations Specialist role will be responsible for performing Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs), associated documents, templates, and processes in compliance with MEDDEV 2.7.1 Rev. 4 and the European Union (EU) Medical Device Regulation (MDR). Your ability to interpret the current, new and changing requirements for clinical research, including use of product equivalency will ensure the proper clinical information about our products is available for use within Philips, contributing to successful transfers of research results to the business and proper compliance with MDR in the EU market.

Your responsibilities

  • Responsible for Clinical Evaluations and writing/updating Clinical Evaluation Reports (CERs) for EU MDR compliance

  • Ensure CERs are updated to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR

  • Drive adoption of compliant clinical data management practices throughout Philips Health Systems, and other Philips (research) groups active in clinical evaluations and/or testing of products involving human beings

  • Actively interface with various internal and external stakeholders, including Clinical Affairs Management and function teams, internal customers

  • Be the expert specialist on an assigned clinical application area

  • Maintain clinical roadmaps

  • Prior experience conducting supporting clinical research in the drug/device industry

  • Advise colleagues in R&D department on new technical and clinical developments

  • Assist during in-house testing of prototype hardware and software

  • Work closely with cross-functional teams to interpret device performance information in clinical settings and in patient use

  • Perform research as needed to provide applicable information about new technology in Diagnostic Imaging

  • Participate in Human Factors / Usability Testing by 3rd party providers, develop protocols, train engineers, and observe testing

  • Identify issues that need resolution to ensure safety and effectiveness of the products

  • Knowledge of how to, or a willingness to learn to, write protocols, reports, and other forms of research projects for various studies that Clinical Affairs is engaged in

We are looking for

  • M.Sc. degree in above mentioned areas preferred

  • 5+ years of critical care experience as medical professional, preferably with cardiology experience in critical care settings

  • Minimum of 5 years direct experience performing clinical evaluations and writing CERs compliant with MEDDEV 2.7.1.

  • Knowledge and experience with Medical Devices Directive 93 / 42 /EEC

  • Knowledge and experience with MEDDEV 2.7.1 Clinical Evaluations

  • Knowledge and experience with MEDDEV 2.12-2 PMCF

  • Knowledge and experience with GHTF SG5/N2R8: Clinical Evaluation

  • Knowledge and experience with EN ISO 14155 Clinical Investigations

  • Knowledge and experience with ISO14971 Risk Management

  • Strong organizational skills, ability to work on multiple projects, and work effectively in a demanding, time-sensitive environment

  • Interest in and passion for research, bringing medical innovations to market and working in multidisciplinary teams

  • Good communication skills, written and verbal

  • Must be available to travel domestically approximately 25%, with occasional international travel

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at on our career website, where you can read stories from our employee blog at . Once there, you can also learn about our recruitment process at , or find answers to some of the frequently asked questions at .