Cerner · Publicerad 26 mars 2021

Company description:

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.
+ Läs mer om företaget
Sista ansökningsdag
Löpande
Omfattning
Heltid
Antal Tjänster
1
Yrkesområde
Data & IT
Underkategori
IT-Konsult

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