Senior Regulatory Affairs Specialist

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.

* 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.

* 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.

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