Quality Regulatory Affairs, Angiocare

Established in 2003, Angiocare is a leading distributor of interventional cardiology, radiology, oncology, neuroradiology, venous diseases and gastro-enterology within the Benelux region. Angiocare has developed strong relationships with both the medical and industry communities over the past 20 years, which has gained them loyalty and trust within the market. Angiocare is part of the Uniphar Plc group based in Dublin which comprises of several Medical Device distribution businesses across 14 European markets with direct operations in Ireland, Northern Ireland, U.K., The Netherlands, Belgium, Luxemburg, Germany, Austria, Switzerland and the Nordics, and is the medical device arm of the Uniphar Medtech Group.

Purpose of the Role
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

Field Actions & Recalls

• 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

EU Medical Device Regulation (MDR) & Local Registries

• 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

Vendor & Product Compliance

• 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

Ethical Compliance & Education

• 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

Quality Management System (QMS)

• 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

Continuous Improvement Projects

• Collaborate cross-functionally to drive quality and compliance process improvements

Role Requirements:

The successful candidate will be hard working and enthusiastic with an interest in quality, compliance and regulatory affairs possibly pursuing further training in this area.

They should have the following skills and qualifications:

• 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

Angiocare is an equal opportunities employer.
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