Philips Regulatory Affairs & Quality Assurance Coordinator in Zaventem, Belgium
Did you know that the average heart beats about 100.000 times daily? And that more than 7 million people each year die from coronary heart disease – so, innovation, prevention, diagnosis and treatment is essential to reduce this number and improve the life of the patient.
At Philips Volcano we are working on industry leading solutions helping clinicians on deciding, guiding, treating and confirming the right therapy for each patient in real-time during image-guided therapies (IGT).
Are you an experienced RA & QA Coordinator with relevant experience in the medical devices or medical equipment industry looking for the next challenge?
If the answer is “yes” Philips Volcano might have the opportunity you are looking for!
Philips Volcano, a Philips business, is a global leader in physiology and intravascular imaging for coronary and peripheral applications. The business also offers a suite of peripheral therapeutic devices. This is part of Philip’s industry leading solutions to help clinicians to decide, guide, treat and confirm the right therapy for each patient in real-time during image-guided therapies (IGT).
As RA & QA Coordinator, you will report into the Q&R Manager, IGT Devices International.
Participate in and advise cross-functional new product/solution development teams on applicable regulations, requirements, and standards (not in the field)
Review development quality reports and plans to ensure that the information required for submissions is adequate
Plan, generate, and coordinate regulatory submissions for product/solution licensing
Coordinate testing required to support regulatory submissions
Review and approve product/solution labeling and product/solution-related marketing communications (generally at BIU and Field)
Maintain existing regulatory filings/ licenses, managing updates and related change control processes (generally at the BIU and field level)
Improve existing processes
Act as a supervisor when needed
We are looking for
Bachelor’s degree in a technical discipline
At least 2-3 years of experience in the medical device industry
Familiarity with preparation and submission of 510(k), PMA, or international documents or registration and marketing of medical device worldwide preferred.
Working knowledge of medical device regulations (21CFR), FDA law, MDD, other global laws and regulations.
Some experience in supporting international registrations and clinical investigations
We welcome you to a challenging, innovative environment with great opportunities for you to explore. Our benefits are very competitive and designed around your preferences:
A competitive salary;
A variable bonus based on both Philips' results and personal performance;
A solid company pension scheme and an attractive health insurance package;
The opportunity to buy Philips shares and products at a discount;
A healthy work-life balance.
If you’re interested in this opportunity to join us, please upload your resume and motivation letter through the Philips career site.
Please note that the closing date of this vacancy is 28.02.2017.
After a pre-selection process, you can receive an invite for a further phone call screening by the Talent Acquisition Consultant. If positive, you will be invited for (face-to-face) business interviews. The screening will take place after the closing date.