Requirements: English
Company: Cure Talent
Region: Alphen aan den Rijn , South Holland
Salary: 77,000 to 92,000 per annum / 6400 to 7600 gross monthly
Cure Talent is thrilled to partner with a leading IVD distributor who, due to their exceptional continued growth, have an exciting opportunity for a Regulatory Affairs Specialist to join their team.
This is a hybrid role with the expectations of being on site 2 days a week.
In this role, you will take a lead in enabling and maintaining regulatory compliance across the EMEAI region. Acting as the Person Responsible for Regulatory Compliance (PRRC), youll manage product registrations, maintain technical documentation, and ensure alignment with IVDR and other applicable directives across a wide portfolio of distributed products.
Key Responsibilities:
- Maintain and update technical documentation and EU Declarations of Conformity
- Manage product registrations and compliance across EMEAI territories
- Oversee post-market surveillance obligations and associated reporting
- Review technical, marketing, and legal documentation for regulatory compliance
- Ensure compliance with relevant directives including IVDR, WEEE, REACH, and ROHS
- Maintain records in regulatory systems such as EUDAMED
- Advise stakeholders on regulatory requirements for labelling and safety documentation
- Collaborate with global regulatory teams and distribution partners to ensure alignment
- Prepare for audits and regulatory inspections
What You Will Need:
- Bachelors degree in a science-related field such as Biology, Chemistry, or Product Safety
- Minimum of 3 years experience in Regulatory Affairs within the medical device or IVD industry
- Strong knowledge of IVDR and international product registration processes
- Experience with ISO 13485; knowledge of WEEE, REACH, and ROHS is a plus
- Excellent written and verbal communication skills in English
- International technical background in pathology or lab equipment is highly desirable
If you are passionate about regulatory affairs and want to play a pivotal role in ensuring global compliance within a respected IVD distributor, we would love to hear from you!