As a senior RA advisor your main responsibility will be to support our customers from the Medical Device and Pharmaceutical industries concerning the following:
- Interface with other consultants and the client’s representatives to successfully manage projects, deliverables, and compliance with quality expectations and deadlines
- Provide information and advice to clients on the regulatory processes for medical devices
- Provide regulatory intelligence, documentation management and document reviews
- Prepare regulatory strategies documenting the most suitable pathway for regulatory approval
- Optimise or assist in preparing technical files
- Prepare submissions and ensure proper communication with competent authorities
- Support management with contract leads, client meetings and proposal follow up
Qmed Consulting is ISO 9001 certified and you will be responsible, through your daily work, for the maintenance and ongoing implementation of the existing Quality Management System in all relevant areas.
Office based or working remotely from EU or US/Canada.
- Relevant scientific background (M.Sc. Biology, Toxicologist, Pharmacist or similar)
- Minimum 3-5 years’ experience within the Medical Device and / or pharmaceutical industry
- Experience in planning and project management
- Conformity assessment routes according to European regulation
- Device submissions in the US, including Premarket Notifications, de novo Requests for Classification, Pre-Market Approval Submissions, Investigational Device Exemptions and the Pre-Submission Program
- Application of standards and guidelines regarding risk management, quality management, biocompatibility, electrical safety, electromagnetic compatibility, labelling, packaging systems, etc.
- Medical and/or regulatory writing
- Excellent knowledge in English (spoken and written). Company language is English.
As a person you are open and customer-minded with good interpersonal skills. You should be familiar with both teamwork and independent work.
We offer an independent job with new challenges every day and a good and varied work environment.
For further information please contact Helene Quie by e-mail firstname.lastname@example.org
or telephone +45 3050 3842.