Regulatory Affairs Specialist Job at cGxPServe, Austin, TX

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  • cGxPServe
  • Austin, TX

Job Description

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.

Job Tags

Worldwide,

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