Head Regulatory Affairs Projects & Alliances - Switzerland
About us :
- We are 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 our company 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.
- For our RA Projects & Alliances team we are currently looking for a Head Regulatory Affairs to represent and promote company ’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 our company during Alliances’ activity.
- 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 company 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
- 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