Manager Regulatory Affairs
My client, a global medical device company focusing on advancing emergency care and increasing clinical and operational efficiency, is looking to add a Manager to their Regulatory team. This role will be on site located in San Jose, California.
The Manager will be responsible for:
- Managing, directing, and supporting a team of 1 to 5 regulatory professionals and guide on regulatory strategies, submissions, and projects
- Meet with direct reports to review performance, set expectations of goals, and identify any issues
- Establishing and maintaining a system for tracking changes in documents submitted to agencies
- Developing and mentoring Regulatory Specialists, Senior Specialists, and Associates
- Leading regulatory compliance activities
The Manager should have the following qualifications:
- Bachelor's degree in technical or science discipline and 5+ years of Regulatory experience in the Medical Device industry
- Understanding of US and European/international regulations and standards
- Experience working with the FDA
- Experience with medical device regulatory submissions (510(k) or PMA)
- Casual dress/atmosphere
If you are interested in this position, please apply today and do not hesitate to reach out with any questions!