Job Description:
We are looking for a Regulatory Affairs Specialist under general supervision responsible for role-based activities (e.g.: the assembly of documents/deliverables/packages for regulatory activities). Review and evaluate technical validation requirements for paper and electronic submissions. Monitoring of regulations, guidance and standards. GRA system/tracker/database maintenance.)
Essential Duties and Responsibilities:
• Compile and submit, in a timely manner, regulatory documents according to regulatory requirements
• Maintain and update existing regulatory authorizations
• Support regulatory activities relating to specific portfolio of products/projects
• Compile, update and maintain role-based deliverables.
• Represent or lead Regulatory Affairs in small project teams
Skills/Qualities:
• Knowledge of regulations
• Scientific knowledge
• Administrative and project management skills
• Ability to contribute to multiple projects from a regulatory affairs perspective
• Ability to multitask and prioritize
• Interpersonal and communication skills
• Technical system skills (e.g., word processing, spreadsheets, databases, online research)
• Proofreading and editing skills
Education and/or Experience:
Bachelor’s degree or country equivalent in a scientific discipline
Minimum of 2 years regulatory or equivalent experience within medical device company
