Regulatory and quality experience across the Benelux.

As an industrial pharmacist (PharmD) accredited as Qualified Person (QP), Responsible Person (RP) and Responsible Person for Information and Publicity (RIP), I have held senior regulatory and quality roles across leading healthcare companies in Belgium, Luxembourg and the Netherlands.

Welcome to MEDCOR. I look forward to collaborating with you.

My name is Hendrik Staels and I am the owner and founder of MEDCOR BV. I am an industrial pharmacist by training and graduated from the University of Ghent in 2012. After graduating I worked in the life sciences industry before starting my own business in November 2018.

With over ten years of experience across regulatory affairs and quality assurance, I act as Responsible Person, Qualified Person and Responsible Person for Information and Publicity, helping organisations navigate compliance across the pharmaceutical, medical device, cosmetics and food supplement sectors in Belgium, Luxembourg and the Netherlands.

Get in touch on the platform you prefer, and we can talk through what you need.

Contact me

Hendrik Staels, industrial pharmacist and founder of MEDCOR

Where I have held the responsibility.

Reckitt

Regulatory Affairs Manager for OTC medicines across Belgium, Luxembourg and the Netherlands. Acted as Responsible Person for WDA (wholesale distribution) licences and as Responsible Person for Information and Publicity, with local vigilance responsibilities.

Guided MRP and DCP applications with the Netherlands as Reference Member State, advised on OTC pricing dossiers, and provided strategic regulatory advice on medicines, biocides, detergents, cosmetics and food supplements.

PharmaMar

Represented the company before health authorities and trade associations. Built and maintained a GDP Quality Management System, successfully defended through the initial FAMHP audit and consecutive surveillance audits.

Allergan (an AbbVie company)

Regulatory Affairs support for prescription medicines across Belgium and Luxembourg.

Arseus Medical

Installed an ISO 9001:2015 Quality Management System and guided it successfully through certification and recertification audits by a certification body linked to a notified body.

Owens & MinorHALYARD*

EMEA QARA Manager ad interim, from July 2022. Leads the EMEA Quality Assurance and Regulatory Affairs function, ensuring compliance with regulatory requirements, quality standards and corporate policies across the region.

As EMEA QARA lead, ensures compliance with European medical device and Personal Protective Equipment (PPE) regulation, including MDR and PPE Regulation requirements. Oversees vigilance reporting, CAPA and QNC processes, complaint handling, field safety corrective actions (FSCA) and EUDAMED activities, and supports commercial work through regulatory guidance for tenders, product launches, CE marking and customer compliance.

Provides strategic oversight of EMEA quality and environmental management systems, covering ISO standards, SOP governance, document control, internal audits and management reviews. Manages supplier quality, and leads a geographically diverse QARA team of four employees and one consultant. Delivers quality and regulatory training, analyses quality-system performance metrics for senior management, monitors evolving regulatory requirements with global stakeholders, and leads cross-functional QARA and continuous-improvement projects across the region.

Work directly with a senior regulatory expert.

Whatever role or service you need, you deal with the same person from the first call to the final sign-off.

Get in touch