I am currently working with a Global Digital Health company who are looking to add a home-based Regulatory Affairs Expert in Medical Devices to their team.
The organisation, an on-line, subscription based regulatory information provider to the global pharmaceutical and device industries, helps companies stay on top of Regulatory requirements by providing access to their on-line platform compiling reliable and up-to-date global regulatory information from more than 110 countries, regions, and international organizations.
You will join a dedicated and experienced team of senior regulatory experts who together with the Content Manager are responsible for the high quality regulatory content of the Database.
- Drives the Medical Device content work in offering development projects expanding and improving the quality of the Medical Device regulatory content
- Owns (in partnership with the content manager) the Medical Device regulatory content including the relevant expert summaries and cross-country tables covering all countries
- Responsible for ensuring the content quality standards are met at all times
- Responsible for providing high-quality impact assessment of key regulatory documents EU and US
- Collaborates with Local experts and Editorial Team on aspects related to the Medical Device regulatory content
- Responsible for knowledge-sharing and training within the Medical Device regulatory area
- May participate in client meetings as subject matter expert on the Medical Device regulatory content
- +5 years of experience within Medical Device regulatory area (preferably from device company or notified body)
- In-depth knowledge on Medical Device regulations including:
- Clinical trials in medical device development
- Certification/marketing approvals
- Packaging and labelling
- Quality System requirements
- Post-market surveillance and vigilance
- Relevant ISO standards and others
- Ability to assess impact of new regulatory requirements in EU and US
If this looks like it could be the next step in your career, please get in touch as soon as possible for more information!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales