Junto HLS is working directly with Regulatory Leadership at a leading medical device company on a Principal Regulatory Affairs Associate position.

Select Accountabilities:

• 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

Location(s):

• 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.