Our client, a medical device company, is looking for a Regulatory Specialist on a contract basis.
The key responsibilities will be:
• 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.
The ideal candidate will have worked hold a BSc or equivalent within a related discipline.
You will also have worked within Regulatory Affairs within the Medical Device industry and will have experience in 510K submissions.
Practical experience with the preparation and submissions for Class II and III medical devices (EU and USA) is also essential