EU MDR/IVDR Project - Regulatory Affairs
Would you like to be responsible for assisting the team with regulatory implementation of EU MDR.
This position requires a good understanding of medical devices and their use as well as an understanding of the regulatory framework in Europe, MDD 93/ 42/EC and MDR 2017/745.
This position specifically supports implementing the EU MDR globally for our client through execution according to the project plan.
- Applies regulations to business practices and provides regulatory input, advice and guidance as needed
- Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products, under the new EU MDR
- Write, refine, track and coordinate Regulatory corporate procedures for harmonization of implementation of EU MDR
- Support in localization of procedures (from Corporate procedures to Local procedures)
- Respond to requests from different Manufacturers as needed
- Supports Sr. Specialist on coordination of impact assessment of implementation of EU MDR in international licenses, closely with Regulatory Specialists from different regions, and supporting supply chain planning
- Consolidate frequent asked questions in the area of regulatory Affairs to support harmonized communication and clarifications
- Support on preparing materials for training and guidance to Regulatory Affairs professionals, supporting implementation of EU MDR
- Follows regulatory affairs policy and proceduresPlanung, Koordination, Begleitung und Durchführung von Risikobewertungen nach ISO 14971
- Strong writing, communication, and interpersonal skills
- Strong attention to detail
- Ability to multi-task, work with rapid changes, and balance competing priorities
- Knowledge of overall medical devices business and regulatory environments
- Ability to learn and stay abreast of European/MDR-related regulations pertinent to medical devices and biologics.
- Ability to build relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
- Knowledge of EU and other regulatory body regulations
- Ability to identify risk in Regulatory strategies
- Strong problem solving and analytical skills
- Effective negotiating skills
- Self-motivated and capable to work in a diverse, fast-paced and dynamic environment
- Basic computer skills, including Microsoft Office Suite
- Bachelor's degree required; concentration in life sciences, technical/engineering or related field, preferred
- A minimum of 2-5 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
- A combination of education and experience may be considered
SciPro is a people business. We specialise in sourcing, advising and introducing highly skilled life sciences candidates to our client partners across the globe, helping them to achieve their business goals. The art of recruitment isn't solely about filling jobs, it's about matching people with people and creating harmonious and successful working environments. As a leading staffing specialist with offices in the UK, Europe and North America our biggest USP is representing candidates of all levels across Research & Development, Operational Excellence & Performance, Manufacturing Quality, Compliance, Regulation, Data Management, Cost Optimisation and Innovation. We pride ourselves on being able to deliver to almost every requirement in your business, in any location you need it.
Your personal Consultant:
Lead Consultant Switzerland
For questions you can reach me any time by
phone +41 43 508 9217 or email firstname.lastname@example.org.