Regulatory & Quality Manager, NL

MAIN TASKS & RESPONSIBILITIES

• Performing and maintaining all medical device registrations and ensure all products and processes comply fully with MDD 93/42/EEC and MDR 2017/745;
• Reporting promptly and coordinating any recalls or adverse events to relevant competent authorities;
• Performing the qualification and approval of suppliers and customers ensuring that relevant customer complaints are dealt with;
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are in place;
• Being involved in any decision to quarantine or dispose of returned, rejected, recalled or falsified products;
• Engaging with local and functional management to obtain and maintain alignment and support for Quality activities;
• Ensuring the promotion of awareness of applicable regulatory requirements and quality/Environmental management system requirements throughout the organization and develop and ensure relevant training for the organization;
• Reporting to Top Management on the effectiveness of the QMS and the need for improvements;
• Responsible for contact and planning with certification bodies, participating in external audits, follow up on audit discrepancies;
• Person Responsible for Regulatory Compliance (PRRC);
• Conformity of the product device to the Medical Device Regulation and Quality Management System;
• Conformity of the Technical Documentation and EU Declaration of conformity;
• Compliance with Post-Market Surveillance (PMS) following Article 10(10);
• Compliance with the Vigilance Reporting obligations (Article 87 to 91);
• For Investigational devices: Issuance of a signed statement (Annex XV Chapter II Section 4.1)

EDUCATION, EXPERIENCE AND KNOWLEDGE FOR THIS FUNCTION:

• Minimum bachelors degree in pharmacy, medicine, chemistry, technology or natural sciences;
• At least 5 years experience from the Medtech or relevant industry, be well equipped with applicable regulations and be suitable for the task;
• Full professional level in both written and spoken Dutch and English;
• Experience from project management and ability to independent drive projects;
• Full understanding of the management system standards ISO 13485, 14001, 9001;
• Full understanding of MDD 93/42/EEC, MDR 2017/745, FDA, QSR and other countries’ requirements for medical device manufacturers.

Who are we?

United Care Products focuses on the innovative development of medical aids for care and welfare organizations, such as transfer aids, hygiene products and care beds.
We also look for suitable solutions aimed at maintaining independent living, housing and working for people with reduced mobility.

Natural movement, mobility and independence

The high-quality medical aids are developed and manufactured in our own production facility in Groningen. United Care not only supplies the healthcare market in the Netherlands, but also has dealers/partnerships abroad.

Our products are made with care and are of high quality. A fine example of Dutch craftsmanship: “Crafted with Care”.

Thanks to our professional staff and strong partnerships with users and carers, we are able to maintain and increase the mobility and independence of users.

All the services we provide are based on our own philosophy: ‘Naturally on the move’.

You can apply by sending your CV and motivation letter to florian.devos@directhealthcaregroup.com. The deadline to apply is 19 March 2023.

The submission of a Certificate of Conduct is part of the application procedure.

Apply now