Quality Regulatory Affairs, Angiocare
Uniphar Medtech
- Nederland
- Vast
- Voltijds
As Quality Coordinator at Angiocare, you will work closely with the QCRA Manager and collaborate across the Uniphar network to support Quality, Compliance, and Regulatory Affairs. You will ensure ongoing compliance with relevant medical device regulations, manage our Quality Management System, and contribute to a high-performance culture rooted in safety, precision, and innovation.Products: Angiocare offers a wide portfolio of diagnostic and interventional devices, primarily in the fields of Interventional Cardiology, (Neuro)Radiology, Vascular Surgery, Interventional Oncology, Gastro-enterology, Venous Diseases and Diagnostic Imaging.Principal Duties and Responsibilities:Regulatory Affairs
- Manage product complaint reporting: from initial report through investigation and closure in collaboration with internal teams and manufacturers
- Maintain records of all open regulatory queries and follow up until resolution
- Prepare monthly complaint reports for management, ensuring timely close-out
- Coordinate field safety notices and recalls from receipt to close-out with patient safety as a top priority
- Liaise with relevant European Competent Authorities (e.g., Dutch Health and Youth Care Inspectorate) as required
- Maintain meticulous administrative documentation throughout the recall process
- Monitor evolving EU MDR requirements and apply them to Angiocare’s product portfolio
- Administer the Dutch Implant Registry (LIR) and ensure compliance with local registration protocols
- Review and approve regulatory documentation for new products and vendors
- Maintain up-to-date documentation and liaise with vendors for required updates
- Conduct product classification and risk assessments, identifying licensing or registration needs
- Track mandatory compliance training with HR
- Manage requests for educational support and submit Eucomed CVS documentation
- Support documentation related to labour standards for audit preparation
- Support the maintenance and development of our ISO 9001:2015 QMS within QPulse
- Assist in conducting internal audits
- Provide administrative support for our quality communication platform
- Collaborate cross-functionally to drive quality and compliance process improvements
- Fluency in Dutch and English
- Bachelor’s degree in quality, Science, Business, or a related field preferred
- 2+ years of experience in Quality or Regulatory Affairs within medical devices or pharma distribution would be a pre.
- Familiarity with EU MDR and ISO 9001:2015 standards
- Strong interpersonal and communication skills
- High attention to detail, organizational abilities, and proactive time management
- A collaborative spirit and a hands-on, problem-solving mindset
- Passion for continuous improvement and patient safety