JOB DESCRIPTION:
The Regulatory Affairs Specialist III works with a team of regulatory affairs professionals to ensure the establishment of best practices within the assigned area of responsibility.
Key responsibilities/essential functions:
- Support continuous improvement activities, including such areas as regulatory procedure development and documentation, standards compliance, and metrics development and implementation.
- Support regulatory compliance and optimization of quality system procedures relating to new product registration submissions and post market reporting through the development, maintenance and improvement of documented processes.
- Support regulatory inspections as required
- Work closely with regulatory, engineering, marketing, legal, and other professionals across the company to communicate company-wide programs and processes for regulatory compliance.
- Work with regulatory colleagues to ensure a consistent approach to regulations is adopted throughout the business within areas of responsibility.
- Collect & summarize performance metrics to identify program weaknesses & recommend improvements in procedures or oversight.