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.
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 http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . 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 http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .