Ensure regulatory compliance with pharmaceutical products distributed by S&N in BENELUX (AWM division) (10%)
Act as the Responsible pharmacist (RP) of the company as described in current EU guidelines for Good Distribution Practice (GDP) of medicinal products for human use (2013/C 343/01) and in article 90 subsection 2 of the The Royal Decree dated 14/12/2006, and in article 4 subsection b of dated 06/01/1995 and related to the distribution of medicinal products in Belgium and in the Grand Duchy of Luxembourg;
Act as Responsible for medical information (RIP) in accordance with the Royal Decrees of 7 April 1995 relating to the information and advertising concerning medicinal products for human use and the Royal Decree of 11 January 1993 laying down the conditions of supply of samples of medicinal products for human use;
Act as the Local contact person for pharmacovigilance (LCPV)
for the pharmaceutical products Iruxol Mono & Novuxol.
provide regulatory affairs (RA) and quality assurance (QA) activities in relation to the pharmaceutical quality management system of the wholesale distribution license of Smith & Nephew NV/SA.
Ensure regulatory compliance with Medical devices distributed by S&N (AWM & ASD divisions) in BENELUX (50%)
Ensure product monitoring and follow-up complaints Processing processes related to product quality with Benelux production units including materiovigilance, recalls and FSCA activities etc.;
Governance medical device distribution license (webportal FAGG);
Ensure training of medical representatives on Medical Vigilance / Pharmacovigilance Procedures, as well as their role in transferring information;
Tender support for tender applications (CE/ISO certifications, sustainability questionnaires, statements (patents…), GMDN codes…);
Ensure the passing on to the CA of the placing of Class IIa, IIb & III Medical Devices into the market, as required;
Participate as a Regulatory Affairs partner in the launch of new products and packaging projects;
Ensure distribution according to GDP guidelines for MDs;
Supporting customer disputes with S & N lawyers, and other relevant internal and external departments (eg marketing, external advocacy);
Ensure the regulatory follow-up of custom medical devices. Provide submission of activity notifications and follow-up of CA updates as needed;
Coordinate and supervise the submission of the declaration concerning sales of medical devices at the FAGG;
Support RAQA functionalities in SAP;
Ensure the submitting waste tax declarations : of RECUPEL, Val-i-Pac etc.;
Ensure regulatory and normative surveillance in connection with Belgian medical device regulation;
Provide relevant internal local and international divisions about the regulations in the Benelux regarding medical devices.
Quality Management system within the company (BELGIUM/NETHERLANDS) for the distribution of medical devices (30%)
Being represent for the Quality Management system for S & N NV-SA in Belgium and S & N CV in the Netherlands;
Maintain the Quality Management system and certification according to ISO 9001 standard of Smith & Nephew NV-SA and S&N CV;
Organize and support internal and external quality audits;
Participate in group audits (RA/QA/HSE);
Benelux contact for local implementation of S&N global policies & procedures.
Supporting the FraBeNe country cluster (France/Belgium/Netherlands) and EU activities (10%)
Working closely with the FraBeNe cluster leader for coordinated cluster activities when necessary;
Providing KPIs, reports, for BeNeLux for any global QA or RA metrics;
If necessary, participate to coordinated EU synergies/activities around RA and QA.
Management of 1 employee: 1 Regulatory Affairs Specialist
Minimum 5 years in a similar position in the field of medical devices;
Master in pharmacy.
Knowledge of the regulations regarding medical devices;
knowledge of regulations in pharmaceutical products;
Knowledge on Material Vigilance/Pharmacovigilance;
Microsoft Office, knowledge of traceability and complaints treatment systems desirable eg.SAP, Pilgrim.
Good priority management;
Insight into organization & planning;
Analytical & synthetic spirit;
Commitment/communication skills at and with all levels;
Editorial and relational qualities;
Professional English proficiency (reading, writing, speaking).