Regulatory Affairs Specialist - Katalyst Healthcares & Life Sciences
Athens, GA 30601
About the Job
Responsibilities:
- Preparing documentation for international regulatory registrations.
- Preparing technical documentation compliant to MDD and EU MDR.
- Defining worldwide regulatory requirements 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.
- Bachelor's degree in science, Engineering, or other relevant discipline.
- 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.
Source : Katalyst Healthcares & Life Sciences