Are you someone who enjoys driving regulatory compliance in a continuous developing environment? Do you enjoy working together in a global team where you can actively contribute and every new day is unique?
If so, then this role is 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 to keep our products safe.
Who we are:
Ascom, with its Ascom Healthcare Platform, is 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 160 years by providing them with technology to enable them to support their communities.
Our systems are used in over 12,000 hospitals worldwide and handle more than 800 million alerts each year. Our solutions positively impact the lives of everyone who visits 1 of the hospitals or care-homes we work with.
Together we can make a difference in the lives of the people who benefit from our technology.
Why should you work with us?
Ascom Americas has become certified as a Most Loved Workplace® 2023, backed by the research and analysis of Best Practice Institute (BPI).
We offer more than just a job at Ascom, we offer a career with real benefits which include:
- Flexible hybrid work environment.
- Professional development with our global Learning Platform as well as localized internal and external training opportunities.
- Opportunities to cooperate with teams around the world day-by-day and on projects in other countries in addition to your home (role dependent).
- Supporting career agility through internal mobility.
- Working with high-quality medical technology in the healthcare space.
The Role Responsibilities:
- Contribute to the planning and implementation of the regulatory strategy
- Maintain the regulatory conformity, certifications and approvals for assigned product and related services and systems developed or supplied by Ascom
- Work with product development teams to ensure regulatory compliance of design and development processes with procedures, methods and tools.
- Review and approve product documentation, technical file, procedures, work instructions and templates related to Quality & Regulatory activities
- Develop and deliver quality and regulatory compliance training to Ascom personnel and subcontractors.
- Analyze, evaluate and, if needed, report incidents to the appropriate regulatory agencies.
- Represent and support Ascom for regulatory matters towards applicable test houses, competent authorities, notified bodies and standardization committees
Skills and Experience:
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 have to possess the ability to create, maintain and develop relationships with external parties requiring high degrees of tact, diligence and professionalism.
- Bachelor´s degree within Engineering or Science
- Good understanding of product development, manufacturing, quality assurance and/or regulatory affairs for medical devices
- Familiar in interfacing with applicable external test houses, laboratories and notified bodies and supporting R&D in implementing requirements and addressing findings from after such tests
- Knowledge of the US FDA QSR, EU MDR, and of medical device process standards during design, development and post-market phase (preferably also alarm systems (IEC 60601-1-8)), usability engineering (IEC 62366-1), risk management (ISO 14971) standards and guidances regarding clinical evaluation, cybersecurity and post market surveillance also considered as an advantage
- Strong project management skills
- Analytical and communication skills research methodology and scientific writing
- ICT skills and knowledge in Microsoft Office
- Willingness to travel on occasional level
- Very good knowledge of English written and spoken
- Experience with the following management systems: ISO 13485, ISO 9001, ISO/IEC 27001 and in quality audits would be an advantage
To learn more about what we do, visit us at: www.ascom.com
