Clinical Operations Specialist
In this role, you have the opportunity to
Support Philips’ transition into the EU MDR regulated environment. You will ensure that our devices are compliant to global regulations, in order to prevent business disruption in any market. You will partner with other key regulatory professionals to drive consistently good regulatory practices within Philips, contributing to seamless regulatory approvals.
You are responsible for
Provide clinical compliance guidance to drive global initiatives such as EU MDR
Write clinical evaluation plans, reports, PMCF studies, and clinical investigation documents in accordance with the clinical evaluation process and applicable regulatory standards (EU MDR, MEDDEV and ISO)
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
Provide 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 and work with stakeholders for CAPA resolution
Provide support during certification audits and regulatory inspections
Communicate strategy and compliance activities to internal stakeholders
Maintain clinical compliance files and tracking databases as required
Communicate with regulatory agencies as needed
You are part of
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. This exciting opportunity is supporting Philips’ transition into the EU MDR regulated environment. This position works in partnership with R&D, marketing, regulatory, quality, and legal among other functional areas.
To succeed in this role, you should have the following skills and experience
Bachelor’s degree is required (Health or Life Sciences required)
3+ years of clinical experience (working in clinical environment or clinical research) required; prior experience with medical device quality systems 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
May require 5% travel annually with possibly some international
In return, we offer you
Working in the medical industry brings much fulfillment, as well as unique opportunities to grow. By taking pride in all you do and inspiring others around you to prioritize Quality above all else, you’ll be contributing to a higher Quality of life for billions and helping Philips deliver innovation that matters.
We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
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 .
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.
As an equal opportunity employer, Philips is committed to a diverse workforce. In order 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.