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SalaryBlyth
Vollzeit
The Job Responsibilities
Working within the Sales & Service Quality function for Draeger Safety UK Ltd who are acting as the UK Distibutor of medical devices for and on behalf of Draegerwerk AG & Co KgaA
The role is to support Draeger Safety UK Ltd by ensuring they remain compliant with local and international regulations – UK Conformity Assessed (UKCA) Medical Device Regulations (MDR), thereby ensuring our German manufacturer can place medical devices and products onto the UK & Ireland markets.
Regulatory Affairs
- Management of the online MHRA Portal to register medical devices for the UK & IE.
- MHRA Portal data maintenance to ensure accuracy and precision
- MHRA Portal - Management of ‘Letters of Designation’ for varying manufacturing sites
- Collaboration with Draegerwerk AG & Co KgaA – ensure technical documentation availability & accuracy for the registration of medical devices
- Management of the 2028 transition of all products from CE to UKCA marking from a distributor perspective
- Regulatory updates - To support the German manufacturer when regulation changes could impact the UK & IE markets. Provide the necessary expertise and guidance to ensure continued supply of goods to market (Regulatory Affairs Requests)
- Act as the ‘UK Organisational Lead’ for all formal communication between the MHRA/HPRA and Draeger UK Ltd
- Clear understanding of GMDN / UDIDI Classifications
- To ensure all distributor responsibilities are completed and updated accordingly
- Support the Purchasing Organisation with onboarding new suppliers
- Collaborate with varying functions over multiple sites with regulatory queries to ensure compliance
- To coordinate and guide all manufacturing sites, Project Steering Boards and Regulatory Account managers to act on United Kingdom Conformity Assessed (UKCA) activities.
- Work in conjunction with Regulatory Authorities to:
- Provide all necessary information in line with MHRA requests
- Be the interface between Competent Authorities and the Manufacturer
- Provide input to alerts that Competent Authorities publish regarding Draeger products
Reporting:
- Monthly scorecard data
- Commercial Lead Team monthly presentation
- Annual Management Review
Other
- Lean 6 Sigma approach to all tasks
- Complete all necessary and relevant training in line with TC Manager.
- Other tasks as required by the Senior Quality Engineer
Your Qualifications
University Graduate with a Science or Business degree (essential).
Lean Six Sigma knowledge (desirable).
The Dräger Workplace
- 27 days holiday plus bank holidays, with option to purchase up to 3 additional days
- Flexi scheme
- Hybrid working available
- Discounted critical illness cover, dental cover and partner life assurance
- Healthcare cash plan
- Discounted shopping & leisure vouchers
- Car scheme
- Cycle to Work scheme
- Gym membership discounts – up to 25%
- Charity Giving scheme
Who we are
From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into ›technology for life‹.
What we offer
If you have any questions, please contact
Nicole Stoker
nicole.stoker@draeger.com
