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Head Regulatory Affairs Projects & Alliances Basel Switzerland,  


Posted on : 26 January 2017

Project Description

Head Regulatory Affairs Projects & Alliances About us The Straumann Group is a global leader in implant, restorative and regenerative dentistry. We offer our products and services to dental professionals and dental laboratories around the world. Our aim is to partner with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape our future and create impact. Encouraging leadership and inspiring ideas from our people has guided us through our proud history of pioneering innovations. You are someone who wants to shape your own development and Straumann s future. You are looking for a company that allows you to create impact and leave an unforgettable footprint. For our RA Projects & Alliances team we are currently looking for a Head Regulatory Affairs to represent and promote Straumann s interests to various government officials and regulatory agencies focusing on BRIC countries. Acting as Head RA Projects & Alliances you will work closely with our VP Corporate QA/RA in representing Straumann during Alliances  activity. Are you looking for a new challenge in an agile and rewarding environment? Feel free to send us your application today! Your tasks Collaborate with our global marketing team (Customer Solutions & Education) to plan and coordinate regulatory strategy and submissions and support on going and future submissions for IRA Work closely with Business Development to plan and coordinate regulatory strategy and projects Partner with Instradent (Instradent is part of the Straumann Group and acts as a business platform to drive and manage the distribution and internationalization of brands for tooth replacement solutions such as dental implants and prosthetics) to plan and coordinate regulatory strategy and submissions Monitor the regulatory environment globally and provide assessments of the impact of new and changing regulations Have a deep understanding of policy development, regulatory processes, and contacts, with a particular focus on BRIC Direct and coordinate activities concerned with the submission and approval products to government regulatory agencies Provide guidance to project team members regarding regulatory compliance issues Oversee the preparation and maintenance of regulatory submissions and files for IRA Establish accountability for preparation of necessary outlines, summaries, status reports, charts and slides Provide overall management of the Regulatory staff development and budget to support business objectives Collaborate with the management team in establishing short and long term strategic goals and direct implementation to achieve objectives Drive learning initiatives and training of RD&O employees on current and emerging regulatory and related requirements Develop and monitor appropriate metrics to track quality / regulatory and process improvement Your profile Undergraduate degree in related field, advanced graduate studies preferred 8+ years  international expertise in Quality Assurance and Regulatory Affairs Significant experience in medical device Quality and Regulatory management Profound know-how of Class II and III medical devices Expert understanding of medical device regulations Management experience highly desired Fluent English, any other language an asset Ability to deliver high complex information in a clear, structured, and compelling manner both to a technical and non-technical audience Inspiring personality, able to present to and engage a large audience and build effective relationships Deliver what you promise, tackle challenges and go for it  with passion! Embrace change and adapt proactively, showing a can-do  attitude Dedicated to developing an organizational culture that promotes and sustains quality and regulatory affairs as an element of excellent business performance Interested? (Please note that we do not accept applications neither CV's from any recruitment agencies) Send your application to

Locations

Basel Switzerland

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