Senior Medical Device Manager

This position is open at one of our offices in Sweden (Uppsala, Stockholm, Malmö) or in Oslo, Norway.
LINK Medical is searching for a Senior Medical Device Manager. Our business is growing, and the portfolio of cross-functional projects is increasing. As a Senior Medical Device Manager, you will work in close collaboration with members of Medical Device/ In Vitro Diagnostics (IVD) experts across the LINK Medical organization.
Responsibilities
· Plan and execute the development of regulatory strategies and development plans for new products including life cycle management.
· Provide regulatory expert advice in projects and line related activities.
· Communicate and participate in meetings with Competent authorities and Notified bodies, partners and clients.
· Prepare and revise Technical Documentation / Design Dossier Documentation.
· Compile, review and approve documentation in accordance with European regulations for Medical Devices (MDR/IVDR).
· Guide clients in processes for Design Control and Risk Management.
· Plan and execute Clinical Evaluation and Performance Evaluation for Medical Devices / In Vitro Diagnostics.
· Support and guide clients in implementation of quality systems according to ISO 13485.
· Manage and execute projects in an efficient and timely manner and within budget.
· Develop training material and conduct internal and external courses.
· Represent LINK Medical for regulatory services within Medical Devices and In Vitro Diagnostics at conferences and webinars.
· Communicate with customers in projects and contribute to further develop LINK Medicals processes and services.
Desired qualifications
· Natural science degree at university level or equivalent.
· 7-10 years’ experience in Medical Device / In Vitro Diagnostics development, production, and/or regulatory affairs.
· Fluent in Norwegian or Swedish, and English.
Personal characteristics
· Takes initiative, acts with confidence, and works independently.
· Initiates and generates activity, internally and externally.
· Takes responsibilities for actions and projects.
· Develops job knowledge and expertise through continual professional development.
· Shares expertise and knowledge with others.
· Demonstrates an interest in and understanding of others, motivates and builds team spirit.
· Identifies and creates business opportunities for the organization.
· Produces the highest quality work, while maintaining professionalism, and courteous attitude with clients and fellow team members
LINK Medical offers an exciting and challenging position in a European CRO and Regulatory Service provider that has a strong local presence. The company focuses on collaboration, sharing of experience and continuous development of our employees. You will be given engaging assignments requiring efficient collaboration with industry partners, clinical and scientific teams and the regulatory authorities. We offer a competitive compensation and benefit scheme for all employees.
Contact information
If you would like to know more or have any questions about the position, please contact Marit Erlien, Group Manager Regulatory, Norway (marit.erlien@linkmedical.eu) or Kristine Nygren, Director Regulatory, Sweden (kristine.nygren@linkmedical.eu).All applications are treated confidentially.
Last day for submitting your application: 2024-03-01.