Regulatory Affairs Specialist

Company : Katalyst Healthcares & Life Sciences

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:

• Bachelor's degree in science, Engineering, or other relevant disciplines.
• Minimum 5-8 years' experience in Regulatory Affairs in the medical device industry.
• FDA, EU, Health Canada, and international registrations experience.
• Working knowledge with quality system regulations and guidelines.
• Ability to develop clear, concise, and timely oral and written reports.
• Great communication skills with all levels of personnel.
• High level of organization and planning skills.
• Working knowledge of medical devices, procedures, and terminology.
• Drug-combination experience a plus.

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