Regulatory Consultant (m/f) - Active Medical Devices

68161 Mannheim
03.02.2018

Daten dieser Anzeige

Job-ID: 007080590
Regulatory Consultant (m/f) - Active Medical Devices

via Optares GmbH & Co. KG

Germany

http://stellenmarkt.sueddeutsche.de/direkt_bewerben/regulatory-consultant-m-f-active-medical-devices-3835465

Preparation of regulatory documents in compliance with regulatory standards Auditing according to EN ISO 13485 and 93/42/EEC or 90/385/EEC (Focus on active medical devices) Developing / compiling technical files and design dossiers Maintenance of contacts with the clients and regulatory authorities (e.g. Interactions with notified bodies) Strategic planning and preparation of regulatory submission documents, interpretation of regulations and compliance with regulatory guidance Support of the management with implementation of strategies and policies Ability to travel locally and internationally, as required

We are searching as soon as possible for a dedicated and experienced Re­gu­la­to­ry Con­sul­tant (m/f) - Ac­tive Me­di­cal De­vices Standort: Großraum Mannheim Kennziffer: 23156 Your tasks Preparation of regulatory documents in compliance with regulatory standards Auditing according to EN ISO 13485 and 93/42/EEC or 90/385/EEC (Focus on active medical devices) Developing / compiling technical files and design dossiers Maintenance of contacts with the clients and regulatory authorities (e.g. Interactions with notified bodies) Strategic planning and preparation of regulatory submission documents, interpretation of regulations and compliance with regulatory guidance Support of the management with implementation of strategies and policies Ability to travel locally and internationally, as required Your qualifications Educated to degree level (engineering / Master of Science) or with an equivalent combination of qualification and experience Strong knowledge of regulatory guidelines: Medical Device Directive (MDD) - Directive 93/42/EEC and amendments and EN ISO 13485, EN ISO 14971, EN ISO 10993 series, EN 60601-1, EN 62304, EN 62366, etc.) Working experience of at least 3 years in the Medical Devices sector Excellent interpersonal, verbal and written communication skills as well as a strong customer focus Excellent language skills in German and English (spoken and written); additional language skills would be an asset Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills Our company Seit 2003 vermittelt Optares Medical erfolgreich Fach- und Führungskräfte an Unternehmen der pharmazeutischen, biotechnologischen und medizintechnischen Industrie. Dabei profitieren Sie als Kandidat durch unsere langjährige Branchenexpertise und unser weit reichendes Netzwerk zu den jeweiligen Entscheidungsträgern. Wir ermöglichen Ihnen somit den Zugang zu passgenauen Positionen inklusive echten Herausforderungen und entsprechenden Weiterentwicklungsmöglichkeiten. Die professionelle, diskrete und transparente Betreuung unserer Kandidaten während des gesamten Bewerbungsprozesses steht dabei für uns im Mittelpunkt. Your application Ihre Ansprechpartnerin Frau Bettina Cöppicus Senior Personalberaterin Tel. +49 5275 987 7210 bettina.coeppicus@optares.de   OPTARES GmbH & Co. KG Personalberatung und -vermittlung Heiligengeist Höfe 8 26121 Oldenburg www.optares.de Folgen Sie uns auf Follow us Xing LinkedIn Twitter

Pharma, Chemie, Med.-/ Biotechnologie

Projekt- und Produktmanagement/ Qualitätsmanagement

Vertrieb/ Verkauf

Sonstige Branchen

Angestellter/ Fachkraft

Vollzeit

68161 Mannheim