- Excellent opportunity to work for a leading Medical Devices manufacturer
- Excellent opportunity to join a dynamic team, working on exciting MDR projects
About Our Client
My client is a global leading medical devices manufacturer, that globally provide medical technologies, with a diverse range of products.
- Participate on multidisciplinary teams and communicate regulatory requirements effectively
- Be a central resource for Global MDR regulatory teams.
- Act as a source of knowledge and promote standardized MDR approach through: Creation of road maps to MDR information and guidance documents to aid in submission process
- Incorporate new learnings into MDR tools / guidance and disseminate to MRD teams
- Stay abreast of deficiencies and successful responses to update teams to previously accepted responses.
- Assist with MDR questions and give guidance to teams as needed
- Act as deployable resources for teams - Support existing reg teams with knowledge of regulations - MDR projects within Business Units - Coach and mentor on EU requirements - Support response to NB on submissions
- Investigate and recommend solutions to address potential regulatory issues.
- Assist internal MDR team members with data analysis.
- Mentor Regulatory Affairs Associates and Specialists
- Serve as primary regulatory contact to the Business Units for escalated MDR issues
- Member of Independent Review Team
- Maintain electronic and paper regulatory files as required by departmental procedure
- Provide other department support as required by immediate supervisor.
The Successful Applicant
- Degree; desired four-year college degree in Science or Engineering disciplines.
- 7+ years medical device industry experience; 5+ years' experience with Class II or higher medical devices
- Excellent technical writing experience within a medical device environment - essential
- Attention to detail and accuracy - essential
- Fluent in English, both written and oral - essential
- Ability to work well under deadlines and pressure
- Problem solving skills for developing creative solutions and meeting objectives are required.
- Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel) Excellent analytical ability
- Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management.
What's on Offer
Competitive package available