Regulatory Affairs Manager
Regulatory Affairs Manager
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Job Description
Are you experienced in regulatory affairs and passionate about medical devices Join Oticon Medical as a Regulatory Affairs Manager.
At Oticon Medical we develop and market bone-anchored hearing systems to help people with hearing impairment. Our product portfolio covers medical devices including electronics and software implantable devices surgical instruments and accessories ranging from class I to class III.
As a Regulatory Affairs Manager at Oticon Medical you will be the regulatory expert for an assigned product area ensuring compliance throughout development and post-market phases. The product area assigned to this position is our sound processors software and related accessories.
This position can be based either in our office in Gothenburg Sweden or Copenhagen Denmark.
Your Role
As Regulatory Affairs Manager your main tasks will be to:
- Represent QARA in cross-functional development projects establishing regulatory strategies and ensuring development projects comply with the company QMS.
- Ensure development and maintenance of technical files for our products
- Drive and oversee risk management activities.
- Review and summarize scientific and technical data providing support to developers regarding requirements testing and acceptable deviations.
- Manage submissions for CE marking and FDA clearance and provide support for global registrations.
- Support marketing and product management with review of product claims during the development and review of product labelling and marketing campaigns.
- Support the clinical team with documentation and strategies for clinical trials.
- Ensure ongoing regulatory compliance for marketed products assess product changes and implement updates to meet new regulations.
Your Profile
A higher education in science or an equivalent background is required preferably with experience in active medical devices and electrical safety.
Familiarity with regulatory frameworks covering software cybersecurity electromagnetic compatibility (EMC) and Bluetooth Low Energy (BLE) is a merit.
Furthermore you are/have:
- agile with a practical mindset product focused and capable of translating technical challenges into documentation and regulatory requirements.
- minimum 3 years of experience in QA/RA preferably in medical devices.
- strong knowledge of MDR ISO 13485 MDSAP and QSR.
- able to communicate effortlessly in English.
- willing to travel (10 days/year).
Why Oticon Medical
Join a collaborative and dynamic team in a trust-based environment where innovation drives better hearing solutions. Were a fast-growing company dedicated to making a difference in peoples lives through advanced hearing solutions.
Apply Now!
Submit your CV and application through our online system by. We do not accept applications via email. Please note as well that the position might close before last application date so dont hesitate to apply.
For questions contact Anders Johansson Director QARA
Required Experience:
Manager
Employment Type
Full Time
