Description
Regulatory Specialist (Medical Devices)6 Month Contract
£40 per hour
Oxford
Optimus Life Sciences are working with an innovative branch of a well-known pharmaceutical company which produces a market changing companion device for people with Diabetes.
We are looking for a maternity cover contract lasting a minimum of 6 months, to be based in the regulatory department. The role requires a sound knowledge of medical device regulations; in particular, technical files.
The position will be full-time on-site in Oxfordshire and can offer 1 to 2 days homeworking a month.
The role is due to start in January but can be brought on sooner if the right candidate is available.
Core Tasks
- Be responsible for implementing an effective program to ensure that all EMEA registrations including Technical Files and country-specific registration of products are achieved to an agreed schedule as well as working with the UK Regulatory Affairs Manager to develop and implement strategies that will ensure the timely introduction of products onto the international market.
- Prepare complete and scientifically sound Regulatory submissions and implement the creation and development of Technical Files for both the IVD and Medical Device Directives.
- Implement a rollout program for existing products and new launches and interact and work with country regulatory contacts to resolve issues arising during the regulatory submission review process to ensure timely approval.
Requirements
- Educated to degree level or above in a Scientific, Engineering or related field with experience of working within Medical Device Regulatory Affairs.
- Experience in Regulatory Submissions for IVDs and/or Medical Devices and experience of working within the requirements of ISO13485, MD directive 93/42/EEC and IVD directive 98/79EC
- Strong organisational, analytical and communication skills.
Interviews are ongoing so apply now if you are interested - thanks!