Senior Regulatory Affairs Specialist/Manager
Pay: $50.00 - $80.00/hour
Under the direction of the MDR project leader, the Senior Regulatory Specialist/Manager will oversee and provide regulatory support for the European Medical Device Regulation (MDR) project and Global Label Transition Project.
Key responsibilities include:
- -Serve as the Senior Regulatory Specialist/Manager of the team and may oversee work performed by up to 2 regulatory specialist on the team.
- -Represent regulatory in cross functional team(s) and manage actions required of regulatory to bring technical documentation in compliance with applicable regulatory requirements.
- -Partner with and provide regulatory support to regulatory contact in the market units.
- -Collaborate with program / project managers and other stakeholders to plan, monitor, prepare and track regulatory submissions within established timeline.
- -Prepare global regulatory strategies and technical documentation for subsequent submission to regulatory bodies.
- -Prepare and ensure official letters and their legalization in accordance with country requirements.
- -Coordinate application of government certificates and their legalization according to country requirements.
- -Oversee and ensure regulatory documentation is archived according to procedure.
- -Oversee and ensure regulatory databases are updated in a timely manner.
- -Assure efficient and timely communication throughout projects.
• Bachelors degree in related field desired
• 5+ years of experience in Regulatory Affairs