Regulatory Affairs Specialist - infection control / medical devices
Belgium - home base near Antwerp or office base in Antwerp, Home Based
A newly created role for a Medical Device Regulatory Specialist to join a fast-growing international infection control business. The company has a large portfolio of professional use disinfectant products used by hospitals and healthcare providers globally. This role will act as Person Responsible for Regulatory Compliance (PRRC) under the EU MDR and, in conjunction with the global regulatory team, work on the registration and maintenance of EU and global medical device products.
This role is based with the EU Authorised Representative (EAR) of a global business and you will act as PRRC in order to advise the business and ensure compliance. You will work as an extension of the UK based global regulatory team and focus on the registration and maintenance of class IIa and IIb medical device products. Duties will include developing regulatory and compliance strategy, providing regulatory expertise to multi-disciplinary product development teams, creation and maintenance of product technical files and product design dossiers, working with technical experts to define and generate validation and verification data, new product registration, maintenance of existing authorisations and acting as a source of regulatory knowledge for the business.
We are looking for a Regulatory Affairs Specialist with existing Medical Device experience; ideally you will have worked with medium-high risk products (classes II and III); you must have a good understanding of the MDD, EU MDR, and ideally global regulatory requirements. You must be able to independently prepare technical files, design dossiers and product registration dossiers. You must be a good communicator able to advise different business functions including QA, product development, QC, validation and sales/marketing.
For further information and an immediate confidential discussion, contact John Sherratt at VRS Regulatory, quoting job reference VRSREG1777.
Regulatory affairs, registrations, compliance, medical device. Infection control, disinfectant, MDD, EU MDR, (EU) 2017/745, 93/43/EEC, MDSAP, CER, QMS, ISO13485, product registrations, data generations, product maintenance.
VRS Regulatory is the Regulatory Affairs and Risk Assessment division of specialist scientific recruiter VRS. We focus on recruitment in Regulatory Affairs, Registrations, REACH, CLP, SDS Authoring, Product Safety, Compliance, Risk Assessment, Regulatory Toxicology, Regulatory Ecotoxicology and Environmental Fate in the chemicals, agrochemicals and biocides sectors.