Regulatory Affairs Specialist IVDR
Regulatory Affair Specialist IVDR(Contract)
Duration: 8 months (with possible extension and/or Philips transfer in time)
Budget range: €3.500 - 4.700 per month
In this role, you will have the opportunity to:
To make an impact in our department with your expertise in regulation about In-Vitro Diagnostics IVDR. Must have experience for this position.
When you choose to work at Philips you’ll work on life-changing projects; and contribute to innovative health technologies and solutions that improve billions of lives around the world.
You will be responsible for:
Responsible for developing and implementing global regulatory strategy to phase out several product lines
Create, maintain and execute plans for phase out / phase in of the product lines in line with EU MDR and certificate changes (address and legal entity)
Responsible for the planning, coordination and preparation of document packages for regulatory submissions for released products.
Assure regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
As part of the product maintenance and development projects, perform the regulatory affairs activities
Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
To succeed in this role, you should have the following skills and experience:
The standards for the devices in scope for this role, include Software as a Medical Device (SaMD) and Hardware and Software configurable Devices, IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 62366, ISO 15223-1, and ISO 20417, IVDR/MDR.
Product is targeted at sales worldwide which means medical device regulations following the QMS and in collaboration with counterparts in the target countries.
Special in above is the IVDR.
In return, we offer you:
For this project, you’ll work for Philips and become a contract or permanent employee of YACHT (a Randstad company). As a contractor at Philips you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional. And as a YACHT employee, you can expect to receive ongoing support with your personal development and future prospects.
YACHT provides all employees with a range of benefits, including pension, social security payments and potential to earn a quarterly bonus as well as a mobile and travel allowance.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.