Philips Clinical Operations Specialist in Pune, India
Medical Affairs role will be responsible for medical input into safety assessments across product development and life-cycle management, including risk management files, complaints, and risk-benefit assessments. Leading 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) is a key responsibility for this role. 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.
In-depth expert in processes for safety assessments & surveillance, complaint analysis, & benefit-risk assessments
Conduct evaluations of safety information from multiple sources
Key input into clinical evaluation plans and reports, safety related sections of regulatory submissions and other safety related documents (e.g. RBA, protocols, CSR, CERs, etc.).
Medical input to MARCOM review
Lead critical literature searches to support all clinical evidence need
Lead medical literature review activities to identify any potential safety information.
Support customers re safety, efficacy, and proper product usage as needed.
Critical evaluation of current lit & competitive activity
Provide LC support in evidence dissemination plans including scientific communications, medical liaisons management, promotional material review, medical information requests,
Oversee and participate in 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
Actively interface with various internal stakeholders, including R&D, Post-Market Surveillance, Risk Management, Clinical Development, Regulatory Affairs, and other internal customers
Establish a global network of contacts in the clinical and medical Diagnostic Imaging community
Advise colleagues in Product Marketing and Applications on new technical and clinical developments, assist in writing commercial and technical documents
Advise colleagues in R&D department on new technical and clinical developments
Assist during in-house testing of prototype hardware and software
Interacts with Clinical Scientists on sites, provide first-line helpdesk support for research related questions
Work closely with cross-functional teams to interpret device performance information in clinical settings and in patient use
Work closely with R&D Engineers, Product Managers and Regulatory Affairs to provide in-depth human physiological knowledge in support of product development and international/domestic product registration
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
MD degree, complemented with at least 5 years of relevant experience in qualify based on individual skills and personality
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
Bringing patient-centric voice to development of innovations, working in multidisciplinary teams
Good communication skills, written and verbal
Must be available to travel approximately 25%, including 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 .
- Philips Jobs