This Medical Device client is looking for a Regulatory Specialist to help support with the EUMDR
40 hours across 5 days
Located in West Yorkshire
To provide assistance in preparation and submission of global regulatory documents under little or no supervision.
- Provides independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches. Inclusive of site transfer activities
- Leads the submission of licenses and authorizations for the maintenance of existing products, international registrations, and dossiers.
- Guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials.
- Defines data and information needed for regulatory approvals.
- Develops labeling specifications and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Provide Regulatory Affairs support during internal and external audits.
- Plans schedules for regulatory deliverables on a project and monitors project through completion.
- Assists in the development of best practices for Regulatory Affairs processes.
- Represents Regulatory Affairs on cross-functional project teams.
- Partners with other functions to define and obtain data to assist with regulatory submissions.
Need to have independence as well as excellent leadership skills to be able to support internal collaborations
EDUCATION & EXPERIENCE REQUIREMENTS:
Practical experience with the preparation and submissions for Class III medical devices ( EU and USA)
- BS with minimum 6 years of experience or equivalent
- Substantial experience of US, EU and International Regulations
- Class II medical devices experience is also preferred
- Knowledge of Additive manufacturing technology and associated regulations (Software), advantageous.
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 Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales