Philips Clinical Scientist in San Diego, California
As the Clinical Scientist, you will support premarket approvals, including defining data and documentation strategies and managing any related reporting, submissions, and clinical claims for the company.
Generate Clinical Evaluation Reports (CERs) that are compliant with MEDDEV 2.7.1 revision 4 and the soon-to-be-released Medical Device Regulation (MDR)
Provide Health Hazard Evaluations (HHEs) and clinical assessments to support Quality Assurance and Complaint Handling activities
The incumbent will play a vital role in CE Marking of current and future Image Guided Therapy (IGT) products
5 most important responsibilities:
CER generation with minimal oversight
HHE preparation for cross-functional review and editing
Clinical assessment drafting for Quality Assurance
Author balanced summaries of peer-reviewed medical publications
Support Business Development due diligence efforts
Philips Volcano, Image Guided Therapy (IGT) Devices, Scientific Affairs Department
Most important stakeholders: Quality Assurance, Regulatory Affairs, Reimbursement, General Counsel, Training and Education
The incumbent will have cross-sector and multi-national collaboration opportunities
Our team is currently comprised of 4 members, 2 of us are San Diego-based, and 2 work remotely; despite our geographic separation, we are tightly knit and genuinely care about each other personally and professionally; we succeed because we trust, respect, and communicate freely with one another
Advanced degree (e.g., MS, MD, PhD, PharmD) in a scientific discipline
Minimum of 3 years medical device industry experience in a Clinical, Scientific, Regulatory, and/or Medical Affairs role
Track record of successful Clinical Evidence Report (CER) generation
Direct experience with adverse event (AE) / serious adverse event (SAE) evaluation for both pre-market and post-market medical devices
Excellent written and verbal English communication skills
What you will bring
Direct experience with generation of MEDDEV 2.7.1 revision 4 compliant CERs
Detailed knowledge of the nature and impact that the transition from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR) will have on Manufacturers and Notified Bodies
Experience as a health care professional (e.g., as a nurse, nurse practitioner, physician, physician’s assistant, medical imaging technician, pharmacist, etc.)
Location: San Diego, CA
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
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Find out more info about Philips at www.philips.com/na/careers
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 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.