| Medrad, headquartered in Pittsburgh U.S.A., is a worldwide market leading manufacturer and distributor of high tech medical devices that enable or enhance diagnostic and therapeutic medical procedures for computed tomography, magnetic resonance and cardiovascular applications. With offices in 18 countries and more than 2.000 employees worldwide, Medrad's sustained success is grounded in a philosophy that focuses our energies on three priorities: customer satisfaction, financial performance and employee development. Medrad is a subsidiary of Bayer AG Healthcare, which is among the world’s foremost innovators in the field of pharmaceutical and medical products. The company culture is characterized by hands on mentality, innovative, lean & mean, pioneer spirit and a trusty family atmosphere. |
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As the senior regulatory & quality specialist you will be responsible for providing regulatory leadership for the EMEA region with regards to new and/or modified interventional products entering the region.
You will provide European Authorized Representative leadership to Medrad’s Interventional Division product lines Class II and III products. Therefore you ensure that the MEBV Quality System is both business balanced and compliant to ISO13485:2003. Next to that you provide support for internal and external audits and will be the representative for the competent European authorities. You act as contact for your counterparts in Pittsburgh, United States. You will also be anticipating in handling the process of AE’s, complaints and recalls and be responsible for the day to day shipment. You monitor the regulatory environment and changes in regulation and acting appropriately in such a way Medrad is effectively compliant. Your are located our European headquarters in Maastricht, travelling is required. |
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For this role we are looking for a candidate with a Bachelor degree (BS) in a science or technical arena (preferably engineering). A European RAPS Regulatory Affairs Certification (RAC) is preferred and excellent knowledge of English both oral and written is obligatory. Understanding of Dutch is not required but preferred.
In depth knowledge of European Union Medical Device directive regulatory requirements, preferably within cardiology and interventional products and/or combination. At least 3-5 years in the European Union Medical Device experience with Class II and preferably Class III and 1-3 years of Quality System Compliance experience with ISO13485:2003. Risk Management ISO14971 and Biocompatibility ISO10993experience is required and active experience in conducting procedures in the process of auditing is preferred. Experience within pre marketing and submission interaction is desirable.
You demonstrate high performance orientation, detail orientation and market knowledge showing excellent persuasive skills. Act as consulting partner and demonstrate excellent writing, listening and verbal communication skills. |
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| The company offers a key role in building up the Interventional business in the EMEA region, the challenge to balance compliance with Medrad’s competitive position, staying abreast of the ever-changing quality system and regulatory environment. You will be working in a high quality, dynamic and international organization and will be offered a competitive benefits package. |
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| Mevrouw M. (Melanie) Grooten |
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