Junto HLS is working directly with Regulatory Leadership at a leading medical device company on a Principal Regulatory Affairs Associate position.
- Develop strategies for submissions to FDA and other regulatory agencies
- May provide leadership and direction to assigned regulatory staff
- Prepare FDA submissions necessary for new product approvals/clearances: Premarket notifications – 510(k)s, Premarket Approval Applications (PMAs) and supplements and Investigational Device Exemptions (IDE) submissions
- Responsible for the preparation of Regulatory Assessments and Notes to File for assigned projects
- Coordinate preparation of additional information and data requested by regulatory agencies and prepare appropriate responses to such requests
- Responsible for the day-to day oversight and management of assigned projects
- Independently review and approve relevant documents, including engineering changes, advertising and promotional materials and product development reports
- Develop and maintain regulatory procedures and policies to ensure ongoing compliance of existing and new products
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to Michelle@juntoHLS.com.