|Location: Leeds, West Yorkshire||Salary: Negotiable|
|Sector: Medical Devices||Specialism:|
|Type: Contract||Contact: Matt Henocq|
Senior Regulatory Specialist
* Serves as a consultant and technical expert on Regulatory Affairs matters.
* Under little to no supervision: provides assistance in preparation and submission of global regulatory documents.
POSITION DUTIES & RESPONSIBILITIES:
* 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.
EDUCATION & EXPERIENCE REQUIREMENTS:
* BS with minimum 6 years of experience or equivalent
* Practical experience with the preparation and submissions for Class II and III medical devices ( EU and USA)
* Substantial experience of US, EU and International Regulations required. Knowledge of International Regulations in China, Japan, Brazil and Russia preferred.
* Knowledge of Additive manufacturing technology and associated regulations (Software), advantageous.
Services advertised by Gold Group are those of an Agency and/or an Employment Business.