Regulatory Affairs Specialist

Responsibilities :

• Preparing documentation for international regulatory registrations.
• Preparing technical documentation to compliant to MDD and EU MDR.
• Defining worldwide regulatory requirements are necessary for regulatory approval of products.
• Participating in cross functional teams as regulatory lead.
• Maintaining regulatory documentation to ensure availability for external audits and preparation of submission packages.
• Authoring submissions, researching requirements, setting priorities, and maintaining project schedules.
• Providing guidance and oversight to team members related to regulatory compliance.
• Reviewing marketing literature for compliance with applicable regulations.
• Executing on additional responsibilities as defined by management.
• Act as a Subject Matter Expert (SME) to support internal and external audits.

Requirements :