Manager Regulatory Affairs

Are you a strategic leader in Regulatory Affairs and ready to take on a global challenge? Do you want to do meaningful work? Do you want to make a difference in people's lives? At DORC, we develop and manufacture ophthalmic solutions so people around the world can see again. Then please read on for the position of Manager Regulatory Affairs.

We’re looking for an experienced professional to lead and shape our international regulatory strategy across 165 countries. Join us in making a global impact while driving innovation, compliance, and efficiency.Main responsibilities:

Regulatory Affairs Leadership

  • Lead and manage the global Regulatory Affairs (RA) team across all sites for assigned product lines
  • Define and execute international regulatory approval strategies in line with evolving requirements
  • Oversee global product registrations, ensuring efficient planning and execution
  • Continuously improve registration processes to reduce time-to-market and optimize resource use
  • Manage budgets for registrations and personnel, including resource planning and recruitment

Cross-Functional Collaboration & Process Optimization

  • Drive the implementation and enhancement of RA processes in coordination with key departments (R&D, Product Management, LCM, Quality, Production, Clinical Affairs)
  • Collaborate with local RA/CA teams and Shared Service Centers to align priorities and streamline regulatory and launch activities

Strategic Partnerships & Organizational Development

  • Support the strategic and structural development of RA across product lines and international operations
  • Lead or contribute to global, cross-functional RA initiatives
  • Represent RA in product line management meetings and serve as the primary RA contact for internal stakeholders
  • Provide regular reporting to the RA/CA Business Segment Head on registration status and project progress

Skills, knowledge and experience:

  • A master’s degree (or equivalent ability) in related field and at least 7 Years of working experience in a related field
  • Minimum of 3 years of managerial experience
  • Demonstrated ability to manage and align diverse stakeholders across multiple disciplines and organizational levels
  • Strong knowledge of regulatory compliance within the medical technology sector
  • Solid understanding of business processes, digital transformation in medtech, and principles of operational excellence
  • Proven expertise in international product registration for medical devices across Class I, II, and III, in compliance with global regulatory standards
  • Significant leadership experience, including successful team management in a dynamic, cross-functional environment

Does DORC make you happy?    

Does working for you mean working together? Realising surgical devices together that help to make people see again? With a hands-on and both legs on the ground mentality? Do you want to work for an organisation where you get freedom and responsibility? Where you are fully stimulated to come up with new ideas? And where innovation, quality and technology are woven into the DNA? Then DORC is the place for you.   

Would you like to know more about working at DORC? Then read on here. 

What does DORC have to offer you?  

At DORC, you play at top level. It is therefore only logical that we reward you as a top player. You can expect the following:  

  • 27 holidays and 13 adv-days for a 40-hour full-time job 
  • 8% holiday pay  
  • 13th month
  • Bonus scheme
  • A travel allowance of € 0.23/km  
  • And a non-contributory pension, which means you will receive a substantially higher net salary   

Did you know ...?

DORC, short for Dutch Ophthalmic Research Center, manufactures equipment, instruments and liquids used in eye surgery.

DORC is a ZEISS company, an internationally leading technology enterprise that develops, manufactures and sells highly innovative products and solutions in a variety of business fields, such as medical technology. As a company wholly owned by a foundation, ZEISS is rooted in and committed to responsibility in all its activities.

Will you be our new Manager Regulatory Affairs

Are you up for this? Then apply directly via the red button! Do you still have questions? Then contact Monique Meiling our Global Recruiter: m.meiling@dorcglobal.com.

An assessment or the request for a Certificate of Good Conduct (VOG) may be part of the selection process.

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