As a Junior Regulatory Affairs Engineer, you bridge technical product development, quality management, and global regulations for advanced image-guided therapy equipment at Philips. You build regulatory strategies to bring medical innovations safely and efficiently to market. Your daily impact:
- Develop and execute regulatory strategies for market entry in the US, EU, and Canada.
- Translate FDA guidelines and European MDE/CE regulations into practical technical solutions.
- Prepare international registration dossiers, including clinical evaluations.
- Evaluate product, software, packaging, and supplier changes. • Conduct risk assessments, manage incidents via Trackwise, and support external audits.
Functie-eisen
You will be successful as a Junior Regulatory Affairs Engineer if you have:
- A completed Master's or PhD degree in Mechatronics, Electrical Engineering, Mechanical Engineering, or Biomedical Engineering.
- Completed 1 or 2 academic courses in Regulatory Affairs during your studies.
- Availability to work on-site at Philips in Best for at least 3 days per week. • Fluency in English in both spoken and written communication
Competenties
To master the regulatory field quickly at Philips, you demonstrate:
- Analytical mindset: You dive into complex technical documentation and legal frameworks effortlessly ('blue' energy).
- Authenticity and honesty: You communicate directly, transparently, and clearly with colleagues and regulatory bodies.
- Eagerness to learn: You absorb new technical concepts rapidly and take ownership of your growth.
- Quality orientation: You deliver precise work with meticulous attention to detail and standards.
Arbeidsvoorwaarden
As a Regulatory Affairs Engineer through Randstad Professional, you receive competitive terms according to VvDN standards:
- A competitive salary aligned with your educational background and expertise.
- 25 vacation days per year based on full-time employment.
- 8.33% holiday allowance.
- Pension scheme starting from day one.
- Personal growth opportunities and targeted training via the Randstad Academy.
- A 1-year contract at Philips with long-term career prospects.
Bedrijfsinformatie
About Philips IGT Fixed: Philips leads globally in health technology. The Image Guided Therapy (IGT) Fixed department in Best develops advanced, fixed treatment equipment supporting doctors during minimally invasive procedures. You join an innovative, dedicated team where quality, patient safety, and technological progress come first. About Randstad Professional: As a Junior Regulatory Affairs Engineer, you join Philips through Randstad Professional. Randstad Professional guides your career development. We offer dedicated support during your assignment, personalized learning programs through the Randstad Academy, and ensure your engineering talent thrives.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Randstad Professional. Heb jij een uniek talent? We ontmoeten je graag.