Regulatory Affairs Specialist Med Device

PE Global
14 Aug 2019
11 Sep 2019
Contract Type
Full Time
PE Global is currently recruiting for a Regulatory Affairs Specialist (Med Device) for our leading multi-national Med Device client based in Leeds (12 months contract).
The role:
The Regulatory Affairs Manager will plan, manage and execute all regulatory activities of all levels of complexity for project of responsibility in development and/or supports regulatory activities for assigned marketed product of responsibility.with regards to compliance to Competent Authority regulations. This may include activities associated Contract Research Organizations (CROs) This person will help ensure that all documents for regulatory applications are prepared in accordance with company SOPs, GCP and other guidelines. This position requires that there is participation on project teams, providing regulatory support in the areas of clinical, non-clinical, Chemistry, Manufacturing and Controls (CMC) and other related areas.

• 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.

Education and experience:
• 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.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Amparo on or alternatively send an up to date CV

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