Strategically partner to manage clinical projects globally for both internal and external stakeholders to optimize product life-cycle, with flawless execution. As part of the MA&TC (Monitoring & Analytics and Therapeutic Care) team we leverage advanced technology and deep clinical and consumer insights, delivering integrated solutions to improve people’s health and enable better outcomes across the health continuum.
You are a part of
This exciting opportunity is supporting Philips’ transition into the EU MDR regulated environment. The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe. It is to better identify medical device products and improve transparency through standard data, technological advances and the establishment of an EU database (Eudamed). Similar to the FDA’s UDI, MDR will establish a robust, transparent, predictable and sustainable regulatory framework for medical devices to ensure a high level of health and safety whilst supporting innovation. You will have exposure to a multitude of indications, medical devices, and workflow solutions. This position works in partnership with R&D, marketing, regulatory, quality, and legal among other functional areas. This matrix organization approach will improve collaboration and your learning and development across a multitude of disciplines.
You are responsible for
Provide clinical compliance guidance to drive global initiatives such as EU MDR.
Act as BG clinical lead to drive implementation of Clinical aspects of EU MDR and Clinical Studies processes.
Develop and maintain clinical evaluation reports and literature reviews required for regulatory compliance to EU MDR.
Assist in the review and creation of clinical related procedures to assess their adherence to applicable regulatory standards and corporate goals.
Determine and support the implementation of process improvements and resolution of issues.
Member of a cross functional team responsible for determining clinical strategy.
Responsible for providing clinical insight into product specifications.
Provide input for Design Output/ program deliverables throughout product life cycle.
Provide input into design risk management documents and post market health hazard evaluations (HHE).
Support product usability compliance activities by providing clinical input.
Review and assess potential non-conformance.
Work with stakeholders for CAPA resolution.
Provide support during certification audits and regulatory inspections.
Additionally, the Clinical Compliance Specialist will:
Communicate strategy and compliance activities to internal stakeholders
Maintain clinical compliance files and tracking databases as required
Communicate with regulatory agencies as needed
To succeed in this role, you should have the following skills and experience
Bachelor’s degree is required (Health or Life Sciences required).
Minimum 5 years of clinical experience (working in clinical environment or clinical research) required; prior experience with medical device quality systems preferred.
Experience working in clinical environment is strongly preferred.
Working knowledge of global regulations and standards related to the conduct of medical device/drug clinical studies preferred.
Experience creating and maintaining Clinical Evaluation Reports and Literature Reviews preferred.
Knowledge of research methodology, information management, and experience with research databases (ie. Embase and Medline) and medical writing strongly preferred.
Excellent organizational, critical thinking and problem-solving skills.
Excellent technical writing and verbal communication skills including ability to interact with executive level management and regulatory inspectors.
Understand LEAN concepts, methodologies and deployment.
Proficient computer skills in Microsoft Office.
May require 5% travel annually with possibly some international.
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. Learn more by watching this video .
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/philips-recruitment-process.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
As an equal opportunity employer, Philips is committed to a diverse workforce. In or der to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.