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#LI-medmix

Head of Regulatory Affairs - Full Time - HaagSwitzerland

 

Join medmix division in Switzerland as Head of Regulatory Affairs to help us to take our regulatory activities to the next level. 

 

In this role you will be accountable for:

  • Responsible for all regulatory activities and international regulatory approvals of the Dental, Surgery and Industry business segments
  • Lead a small team 
  • Develop guidelines and processes to ensure regulatory compliance for all business functions of the Business Unit, in particular with regard to the medical device regulation
  • Responsible for the definition and implementation of product approval strategies in compliance with the relevant, country-specific requirements and regulations
  • Support customers for regulatory affairs inquiries    
  • First point of contact for all internal and external customers, certification bodies and regulatory authorities
  • Monitor and assess applicable regulations and guidelines and deploy them to the organization

 

To succeed in this role, you will need:

  • Technical or scientific degree (e.g. engineering, biology, chemistry)
  • 5 year’s minimum of professional experience in research and development or quality management
  • 5 year's minimum of regulatory affairs experience for medical devices in the EU and / or international markets
  • Leadership experience in a matrix organization
  • Well-founded knowledge of MDR, GMP, ISO 13485, ISO 14971 and ISO 10993
  • Pronounced evaluation and decision-making skills 
  • Analytical capability as required in reviewing, assessing and interpreting the relevant requirements
  • Proactive personality with hands-on-mentality, strong communication skills and decisiveness 
  • German and English on a business fluent level

 

Your benefits: 

  • 40 hours working week
  • Generous holiday regulation
  • Contribution to pension fund with very good savings plan options
  • Free company parking
  • Access to various benefits
  • Loyalty bonuses for longstanding employees

 

Location: 

We are based in Haag. A great place with a lot of quality of life, because in the middle of the beautiful Rhine Valley, surrounded by a unique mountain scenery, with varied offers and many sights.

Applicants from EU / EFTA are welcome to apply. Currently, we are not accepting applications from employment agencies.

 

Have a question about the role? Contact Mandy Della Volpe, HR Business Partner, +41 81 414 71 81. We look forward to hearing from you!

About us

medmix is a global leader in high-precision delivery devices. We occupy leading positions in the healthcare, consumer and industrial end-markets. Our customers benefit from a dedication to innovation and technological advancement that has resulted in over 900 active patents. Our 12 production sites worldwide together with our highly motivated and experienced team of over 1’900 employees provide our customers with uncompromising quality, proximity and agility. medmix is headquartered in Baar, Switzerland.

Our shares are traded on the SIX Swiss Exchange (SIX: MEDX).
www.medmix.swiss