At Cerner, we are working at the intersection of health and technology. We create software solutions to support clinicians and healthcare professionals in hospitals and healthcare organisations worldwide.
Job description:
As a Regulatory Affairs Strategist, you will manage the approval and surveillance process for our European software devices according to MDR regulation (EU) 2017/745 and ISO 13485. You prepare and support the creation of technical documentation for approval within Europe and keep them up to date. You assess the further development of our projects in regard to regulatory requirements and standards, influence product design and product development with respect to regulatory requirements. This can be done, for example, by reviewing specifications, monitoring changes, checking evaluations, as well as involvement in error and complaint management.
In addition, in this role, you will work with the development teams, provide regulatory input to support compliance with ISO standards and MDR, as well as participate in internal and external audits. Furthermore, you can expect cross-site and international teamwork.
Required profile:
Basic Qualifications:
Bachelor's degree in a related field, or equivalent relevant work experience
At least 3 years General business, health care, or information technology-related work experience
At least 2 years of experience in Regulatory Affairs
Fluent in English, Swedish
Preferred Qualifications:
At least 1-year medical devices in the EU, CE Marking, ISO 14971, ISO 13485 and software specific development, quality, and safety standards work experience
At least 1-year preparation of submission documents, including technical files 510(k), international registrations
At least 1 year of IT solutions or medical devices work experience
Fluent in German
Expectations:
Proficient with Microsoft Office Suite
Ability to travel 20 %
Excellent communication skills verbally and written
Structured work and sense of responsibility
What we offer:
Cerner is a place where people are encouraged to innovate with confidence and focus on what is important - people's health and the care they receive. We are transforming health care by developing tools and technologies that make it more efficient for care providers and patients to navigate the complexity of our health. From single offices to entire countries, Cerner solutions are licensed at more than 25,000 facilities in over 35 countries.
Cerner's policy is to provide equal opportunity to all people without regard to race, color, religion, national origin, ancestry, marital status, veteran status, age, disability, pregnancy, genetic information, citizenship status, sex, sexual orientation, gender identity or any other legally protected category. Cerner is proud to be a drug-free workplace.
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Om företaget
At Cerner, we are working at the intersection of health and technology. We create software solutions to support clinicians and healthcare professionals in hospitals and healthcare organisations worldwide.
