We are working with an international regulatory service provider in the Life Science sector, specialised in product development, regulatory and market access.
The consultancy is well established and have helped many clients progress their product developments by providing scientific and regulatory advice, through to gaining regulatory approval and marketing authorisation both nationally and internationally, using their global network of specialists.
- Prepare regulatory submissions as required for global approvals for medical devices in vitro diagnostic (IVD) products, including preparation of reports and interaction with regulatory officials as required.
- Prepare and submit to notified body Technical Documentation needed to demonstrate compliance with applicable European Regulations.
- Prepare regulatory submissions for Medical Device and IVD products.
- Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.
- Interface with regulatory agencies for inquiries and issues.
- Support product change control process from a regulatory perspective and life-cycle management of product reports.
- The ideal candidate will have 3+ years of experience in a regulated industry, with at least 3 year’s experience in Regulatory Affairs (ideally from a consultancy background) preparing EU Technical Documentation in IVD.
- Possess a working knowledge of the MDR, IVDR and other applicable ISO standards in particular ISO 13485.
- Demonstrated organisational, planning, and prioritising abilities, as well as strong technical writing ability.
- Demonstrated strong attention to detail; ability to work under pressure to meet deadlines.
- Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.
- Flexibility to adjust to changes in schedule, priorities, product availability and perform multiple tasks.
- Experience in Medical Device or IVD industry, preferably in regulatory affairs and/or quality management related positions; Notified Body experience.
- Customer and solution orientation – this is the DNA of a good service provider.
- Experience, expertise and worldwide networking in over 90 countries.
- Innovative and long-standing customers.
- A family-like and personal team spirit in a modern working environment.
- International diversity – in the team and in the projects.
- Long-term prospects – for professional and personal development, there’s a wide range of tasks and individually tailored training opportunities right from the onboarding phase.
- Flexibility, freedom and personal responsibility – through flat hierarchies, short decision-making processes and family-friendly working time models, with something for everyone.
- The role can be home-based, with occasional travel (travel and accommodation covered).