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:
- Degree with relevant experience
- 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)