Head of Regulatory Affairs

Are you someone who enjoys ensuring and driving regulatory compliance in a fast moving environment with particular attention to software produts? Do you enjoy working together in a global team where no two days are the same? If so, then our Head of Regulatory Affairsrole with us might be what you’re looking for.
As part of our Global Regulatory Affairs team, you’ll be at the forefront of our business and building solutions that ultimately help our customers provide expert care.
Your days will be filled with…
Lead a global team of seven people within Quality Assurance and Regulatory Affairs
Develop, propose and implement regulatory strategy
Maintain regulatory conformity, certifications and approvals for assigned products and related services and systems developed or supplied by Ascom
Work with product development teams to ensure compliance to design controls, design and development processes and procedures as well as methods and tools for product quality and regulatory compliance.
Evaluate and, if needed, report incidents, complaints to the appropriate regulatory agencies.
Review and approve product documentation, procedures, work instructions and templates related to Quality & Regulatory activities
Develop and deliver quality and regulatory compliance training to Ascom personnel and subcontractors.
Represent Ascom for regulatory matters towards applicable test houses, competent authorities, notified bodies and standardization committees
And you are…
Bachelor´s degree within Engineering, Legal or Science
At least 6 years and solid understanding of product development, manufacturing, quality assurance and/or Regulatory affairs for medical devices.
Minimum 4 years experience with the following quality systems regulations: US FDA QSR, ISO 13485, ISO 9001, ISO/IEC 27001 and in quality audits
Expert knowledge of the EU MDR
Expert knowledge in medical device quality management systems (ISO 13485)
Strong knowledge of medical device process standards during design, development and post-market phase including software lifecycle (IEC 62304 and IEC 82304), usability engineering (IEC 62366-1) and risk management (ISO 14971) standards
Strong leadership and project management skills
Strong business-oriented mind-set with the ability to balance regulatory requirements against business needs
Strong analytical, communication and negotiation skills
Willingness to travel
Things move fast at Ascom and to be successful you will need to be team player with a strong drive and a pragmatic and positive attitude. You possess the ability to create, maintain and develop relationsships with external parties requiring high degrees of tact, diligence and professionalism.

We work with an ongoing selection, so submit your application as soon as possible.
Here at Ascom…
You’re not just a number, you’re a person with aspirations and that’s important to us. You can drive your own career and we’re here to help you do that by:
Providing career progression through learning and development, internal opportunities, and being part of global and local initiatives and projects. But don’t take our word for it, just ask some of our team members who have been with us for over 20 years!
Giving you a real-world, first-hand experience about what it’s like to work with technology that is at the forefront of the healthcare industry.
Making a difference and having an impact on the lives in your community.
We are…
A global solutions provider focused on Healthcare ICT and mobile workflow solutions. Headquartered in Switzerland, our business spans across 18 countries, and has been supporting the healthcare industry for close to 160 years by providing them with technology to enable them to support their communities.
Together we can make a difference in the lives of the people who benefit from our technology.
To learn more about what we do, visit us at: www.ascom.com