Are you someone who enjoys ensuring and driving quality/regulatory compliance in a fast moving environment?
Do you enjoy working together in a global team where no two days are the same? If so, then our RA Manager - Patient Systems role 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. You need to be in the Raleigh area so you will have to be able to go into the office when necessary. Hybrid remote - some days in the office are required.
Your days will be filled with…
- Develop, propose and implement quality and regulatory strategy
- Maintain 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 compliance to 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, 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.
- Represent and support Ascom for regulatory matters towards applicable test houses, competent authorities, notified bodies and standardization committees
And you are…
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 relationships with external parties requiring high degrees of tact, diligence and professionalism.
- Bachelor´s degree within Engineering or Science
- Understanding of product development, manufacturing, quality assurance and/or regulatory affairs for medical devices
- Experience 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 US FDA QSR and MDSAP.
- EU MDR and in medical device quality management systems (ISO 13485) considered as an advantage.
- Knowledge 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 guidance's regarding clinical evaluation, cybersecurity and post market surveillance also considered as an advantage
- Leadership and project management skills
- Analytical and communication skills research methodology and scientific writing
- ICT skills and knowledge in Microsoft Office
- Good knowledge of English written and spoken
- (preferable) experience with the following quality systems: ISO 13485, ISO 9001, ISO/IEC 27001 and in quality audits
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.
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