Philips
Regulatory Affairs Specialist (Contract)
Regulatory Affairs Specialist (Contract)
Location: Best, Netherlands
Duration Assignment: 12 months (with possible extension)
Contract: via a Randstad company
Hours/week: 40
Month salary: 3.800,- until 5.300,-
In this role, you will have the opportunity to: Make life better!In this role, you challenge yourself as a Regulatory Affairs Specialist, driving regulatory excellence by enhancing systems and processes to ensure product compliance and market success.
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:
Implementing global regulatory strategies and roadmaps aligned with organizational goals.
Leading safety risk assessments and managing incidents in compliance with Trackwise standards.
Supporting audits and inspections, acting as a mentor to junior team members.
Managing regulatory changes for product labeling, manufacturing, supplier, design, and software compliance.
Facilitating regulatory submissions, including CE Marking and clinical evaluations.
Coordinating with regulatory authorities and certification bodies for product approvals.
Maintaining regulatory filings and supporting UDI/GTIN-related activities.
Reviewing and validating marketing and labeling materials for compliance.
Recommending process improvements and revising regulatory SOPs as needed.
To succeed in this role, you should have the following skills and experience:
Education: Bachelor’s/Master’s Degree in Biomedical Engineering, Business Administration, Health Sciences, Pharmaceutical, Law, or equivalent.
Experience: Minimum 2 years of experience in Regulatory Affairs, Quality Compliance, or Medical Devices Industry (or no experience with a Master’s degree).
Preferred Certification: RAPS RAC certification.
Strong knowledge of global regulatory requirements and quality systems.
Excellent data management, regulatory reporting, and documentation skills.
Ability to lead safety risk assessments and manage regulatory compliance.
Effective project management and stakeholder collaboration skills.
Experience in product registrations and conformity assessments.
In return, we offer you: For this project, you’ll work for Philips and become a contract or permanent employee of 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.
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.