Therapeutic Area: Medical Devices
Resource Required: Regulatory Manager
Resource Experience: Min 5 yrs
Resource Location: US or EU (US preference)
Hours per week: 0.5 ? 1 FTE (from 1 team member, ideally looking at 0.75 FTE)
Target Resource Start: ASAP
Estimated Resource Stop: 18-24 months
Tasks to be assigned to selected resource: Global device experience in regulatory strategy/process/guidance/writing
Class - Class II/III
Off the shelf devices and new devices (end to end)
- Ensure global approaches to the device regulatory strategy of Drug-Device Combination products and Medical Devices with particular focus on the requirements in the US, EU, Japan and China.
- Lead and/or support Drug-Device Combination products and Medical Devices development and global filing activities from a regulatory standpoint from initial product concept through the product life cycle e.g. clinical submissions, technical files, marketing applications, response to questions, post-approval submissions and Agency Briefing Documents.
- Understand and interpret global regulations/ guidelines relating to Drug-Device Combination products and Medical Devices.
- Convey regulatory expectations for the device aspects in a manner that is easily understood by both technical and non-technical teams.
- Act as an advisor and partner with functional units on the implementation of Drug-Device Combination and Medical Device regulatory requirements.
- Provide device-related advice on data management systems
- Agency: Achieva Group Limited
- Contact: Lewis Coulson
- Phone: 01727 811 634
- Reference: BH-31798
Website: Achieva Group Limited
- Posted: 13th July 2021
- Expires: 10th August 2021