QA/RA Manager

Department Info

In 2020, Quirem Medical B.V. was acquired by Terumo Corporation. As a result of the acquisition, Quirem Medical B.V. became part of the Terumo Therapeutic Interventional Oncology (TIO). TIO offers fully integrated solutions for treating liver cancer through radioembolization, chemoembolization and ablation. In our site in Deventer, the Netherlands, our associates are involved in Production, R&D, Clinical & Medical, QA, RA, Supply Chain and Support Services.  

Job Summary

The Quality Assurance & Regulatory Affairs Manager will manage and be responsible for driving Quality & Regulatory compliance while aligning with the overall organization to meet business needs & objectives.

The Quality Assurance & Regulatory Affairs Manager will manage the QA & RA department.

Reports to: VP Quality, Regulatory & Vigilance at Terumo Europe NV

Job Responsibilities

• Act as a leader in the Quality & Regulatory function by designing and implementing Quality systems and advising the Quirem team on Quality & Regulatory standards applicable to the business being served. 
• Ensure that the conformity of devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released.
• Ensure that technical documentations are up to date and comply with all applicable requlations and requirements in the regions where the products are expected to be commercialized as per the quality manual
• Ensure that post-market surveillance obligations are complied with in accordance with regulatory requirements.
• Ensure that the reporting obligations of serious incidents and field safety corrections are fulfilled.
• Ensure the business remains compliant with local, federal and global quality system regulations applicable to the products manufactured, sourced by, distributed and installed/serviced by Quirem.  
• Ensure the proper implementation of and oversee CAPA (Corrective and Preventative Actions), validations, inspections, document control, regulatory affairs, and problem resolution, acting as an advisor. 
• Manage customer quality/regulatory compliance inquiries and visits when escalated to ensure a satisfactory resolution is achieved. 
• Act as the primary interface with external Quality Auditors and Regulatory Agencies / Notified Bodies during on-site audits and their follow-up.
• Act as the Quality Management Representative for the company, fulfilling the requirements of ISO 13485. 
• Act as the Person responsible for regulatory compliance (PRRC).
• Working with R&D and other functions, ensure that design & change control systems are effective, and provide QA review & oversight to design change/New Product Development projects. 
• Review & approve product labeling / product marketing literature for regulatory compliance and claims support. 
• Coordinate and provide relevant documentation to Regulatory Agencies to enable timely product registrations
• Build and manage annual budgets for the QARA operational work & projects.
   

Profile Description

• Qualified as the Person Responsible for Regulatory Compliance (PRRC) you must have either of the following qualifications:
  • OR:  diploma, certificate or other evidence of formal qualification, awarded on completion of a university  degree or of a course of study recognized as equivalent by the Dutch government, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
  • OR:  Four years of professional experience in regulatory affairs and in quality management systems relating to medical devices.

• We are looking for someone who has experience with production (environment), who is familiar with the associated processes, who can lead research and support projects in Operations.

• Excellent knowledge of ISO13485 and other applicable global regulatory standards 
• Project management experience 
• Excellent interpersonal skills and communication skills, written and oral, in English
• As a true team player, you are in the office in Deventer, the Netherlands, on a regular basis (min 1 or days/week)
   

Offer

We offer a very challenging role within this pioneering division of Terumo. You play an active role to launch our products on a global level, and as such give patients access to our technology to improve the quality of their lives.

You can count on a competitive salary and extra benefits, coaching by your manager and colleagues, and access to a vast amount of training content to develop yourself in a professional way.

Contact Person

Peter Coolen

Talent Acquisition Partner