Internship - Regulatory Affairs

Internship projects vary depending on the needs of both the student and the business. Haemonetics interns are assigned to a meaningful project within the company to acquire a variety of experiences, try different skills, and learn what a future career might offer while also contributing to our innovation agenda by completing business-critical projects and assignments. The Regulatory Affairs Internship will be located onsite 3 days/2 days remote per week in our downtown Boston HQ located at 125 Summer St.

What Will You Do:

• Day to day operations support global submission activity, US state licensing, document legalization and processing, working with cross-functional teams to obtain registration documents, etc.

• Revise labeling review forms and the completion of at least one product specific labeling content template

• Claims matrix implementation for medical device(s) - population and confirmation of content with cross-functional experts

• Review and disposition of existing marketing materials

• Establish best practices for claims matrix and legacy marketing material reviewand obsolescence

• Improvement project for Distributor Submission Checklist -create submission requirements checklist as part of regulatory evaluation process for project team deliverables to support RA submission activity; start with USA, Canada and EU

• Appropriately legalize, notarize, endorse documentation for RA operations support.

Education/Skills:

• Degree program in Regulatory Affairs, Scientific or health-care related field, Life Science, Clinical Sciences, Engineering preferred.

• Courses in regulatory affairs, quality assurance, and clinical research can be particularly beneficial.

• Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel)

• Excellent written and verbal communication skills

• Self-directed and able to work without supervision

• Energetic and eager to tackle new projects and ideas