Smith+Nephew S

Regulatory & Quality Affairs Manager Benelux (BB-F82CA)

Trouvé dans: Xpatjobs BE

1. Ensure regulatory compliance with Medical devices distributed by S&N (all Business Units) in BENELUX (45%) -Ensure product monitoring and follow-up product complaints handling & materiovigilance with global complaints team and Smith & Nephew vigilance team -Ensure products recalls and FSCA activities with local BE and NL Competent authorities, concerned customers and Field Actions team -Governance medical device distribution license (webportal FAGG) - Ensure training of medical representatives on Medical Vigilance / Pharmacovigilance/ complaints handling Procedures, as well as their role in transferring information - Ensure new collaborators induction RAQ training sessions -Tender support for tender applications (CE/ISO certifications, sustainability questionnaires, statements (patents), GMDN codes) - Ensure the notification on to the CA for the placing of Medical Devices into the market for the first time in Belgium as required for reimbursed products -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 -Ensure the submitting waste tax declarations for Benelux : RECUPEL, Val-i-Pac etc. - Ensure regulatory and normative surveillance in connection with local Belgian and Dutch medical device regulation - Provide relevant internal local and international divisions about the regulations in the Benelux regarding medical devices - Regulatory approval of promotional materials for Belgium and The Netherlands - Record any regulatory notification/submission into the RADAR application (regulatory data), provide RA metrics Quality Management system within the company (Belgium/Netherlands) for the distribution of medical devices (45%) -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 Corporate audits (RA/QA/HSE) -Benelux contact for local implementation of S&N global policies & procedures - Participate to the PAN EU QMS development and implementation - Provide monthly BeNeLux quality metrics - Ensure external product suppliers quality agreements are in place and maintained -Support RAQA tasks in SAP (traceability, product blocs/release, quality holds handling) Ensure regulatory compliance with pharmaceutical products distributed by S&N (AWM division) in BENELUX (10%) Act as the Responsible Person (RP) of the company as described in section 2.2 of 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 La Loi relative la distribution en gros des medicaments 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 Belgium: in accordance with article 66 2 of the Royal Decree of 14 December 2006 as amended by the Royal Decree of 28 May 2013 regarding pharmaceutical products for human use for Belgium; For the Netherlands: 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. Activities include but are not limited to: Batch release of Iruxol & Novuxol Approval of sample requests in the Benelux Perform GDP audit of Third Party Logistics service providers Assist the company during GDP audits by the FAMHP Submission of variations/renewals for the pharmaceutical dossier of Iruxol & Novuxol Maintain the Quality Management System of the wholesale distribution license* Provide relevant internal local and international divisions about the regulations in the Benelux regarding drugs Management of 2 employees: 2 RAQA Specialists Benelux REQUIREMENTS OF THE FUNCTION Diploma Master in pharmacy or PhD in science Experiense Minimum 5 years in a si

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location_on Zaventem , Flanders, Belgique

work Smith+Nephew

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