We are currently supporting one of our best clients to identify and appoint a Quality & Regulatory Affairs Manager BENELUX. The business is an instantly recognisable global Medical Brand who specialise in the Medical Device and Pharmacology market ,specialising in Diagnostic and Interventional Medical Imaging.
They are well established across International markets, have a superb reputation with their clients and employ over 2,500 people globally. They are known to develop their staff and reward people professionally and provide an environment that rewards success with internal progression.
In this role you will join an established Quality/Regulatory team and take a key lead in delivering across both functions with a direct focus on established product portfolios in the BENELUX region.
If you are looking for that next development in your career journey and want to progress with a global device brand - This could be the perfect role for you!
Candidates need to have direct experience of working in Pharmaceutical & Medical Industries and have a direct working knowledge of working in the Belgian and Netherlands Regulatory/Quality arenas. French and Dutch language proficiencies are required for this role.
1. Regulatory Affairs
* Is in charge of the local regulatory intelligence and all related tasks.
* Is the contact person dealing with the authorities for RA on his/her perimeter.
* Checks the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department. Submits variations, renewals or new marketing authorization applications to his/her competent authority. Attaches any relevant documentation according to the local requirements. Translates some documents in Dutch (or French).
* Is in charge of the follow-up of the pending approvals. Answers some questions and provides additional documentation when requested by the agency. Informs the Corporate RA department about the approval status of the dossiers.
* Informs the Corporate RA department about new regulations on his/her perimeter.
* Proposes regulatory strategies based on his/her expertise and knowledge of the laws from Belgium, Luxembourg and the Netherlands about medicines.
* Revises and validates the texts of the packaging materials of the products.
* Applies for pricing and reimbursement of the products and follows the decisions of the commissions.
* Is in charge to submit all PV related issues such as the PSURs, new SmPCs and other safety related documents to the competent authority.
* Is responsible for writing and updating the quality documentation related to RA.
* Defines and coordinates the needs for training of all collaborators and the resources involved in RA in his/her subsidiaries.
* Supports all Quality related activities linked to RA, mainly the systematic updating of specifications (Change management), of variations, of packaging (a.o.) influencing market release and GMP compliance.
2. Pharmaceutical and Quality Affairs
* Implements locally the Good Pharmaceutical Practice (GPP) business policy defining a general pharmaceutical quality policy, strategy and objectives taking in account due diligence and general rules of continuous quality improvement (management review, risk management based principles a.o.).
* Ensures that a quality management system is implemented and maintained with clear definition and demarcation of local and global standard operating procedures and instructions.
* Is responsible for the fulfilment of all legal requirements concerning the pharmaceutical activities of the busienss in relation to the function of Responsible Person as defined in the Belgian, Luxembourg and Dutch Law on Medicinal Products and Medical Devices.
* Is the contact person dealing with the pharmaceutical authorities and healthcare professionals on his/her perimeter in order to ensure the compliance with the standards and guidelines of Good Pharmaceutical Practice.
* Prepares and follows the course of inspections and audits including all subcontractors, suppliers of medicinal products and related starting material in close collaboration with company headquarter's quality department. Is responsible for the local implementation of the preventive and corrective actions.
* Updates regularly the technical documentation of the subsidiaries (contract management, licenses, supplier and laboratory authorizations, certifications, product and medical device registrations, customer authorization, reimbursement…).
* Establishes the procedures for purchasing, reception, storage, control, invoicing and distribution of the products and medical devices or with the external distributor and subcontractors. Defines the rules of product and medical device traceability. Verifies customer authorizations.
* Authorizes the delivery or non-delivery of product batches (market release or market rejection) on his/her perimeter according to the Belgian, Luxembourg and Dutch Law encompassing all the responsibilities of a Marketing Authorization Holder.
* Manages product quality complaints effectively.
* Is in charge of product rejection, return including return to saleable stock, quarantine measures and destruction. Checks for counterfeit and falsification and decides about their final disposition.
* Is responsible for any recall operation for medicinal products.
* Writes, revises and gives out technical contracts with all contractors and third parties necessary for the import and distribution activities.
* Ensures that initial and continuous training programs are implemented and maintained.
* Approves any subcontracted activities which may impact on GDP.
* Performs self-inspections at appropriate regular intervals following a prearranged program and that necessary corrective measures are put in place (covering also the inspections).
* Decides on the final disposition of returned, rejected, recalled or falsified products.
Target salary 55,000 - 75,000 basic Depending on experience
15% Annual Bonus with opportunity to exceed
Medical, Pension & Wider package
Key Skills, Qualifications and Client Requirements
The successful candidate will have;
* Working experience of regulatory & Quality Systems in Belgium & the Netherlands
* Ideal experience of working in Pharmaceutical & Medical Device Arenas.
* Be Bi lingual; - French, Dutch & English
* Qualification in Pharmacology / Medical Sciences
These are almost essential requirements - You will need to meet almost all requests to be considered.
What Happens Next?
If you are interested in finding out more about this role please click the 'Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest.
All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent.
Alternatively, to find out more about this role or any other roles that maybe relevant, you can email us at firstname.lastname@example.org or call our Medical Devices team on 01423 813456
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