What are the responsibilities and job description for the Internship - Regulatory Affairs position at Haemonetics Corp?
We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice.
Job DetailsInternship 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
EEO Policy Statement
Haemonetics is an equal opportunity employer. In accordance with applicable law, we prohibit discrimination against any applicant or employee based on any legally-recognized basis, including, but not limited to: race, color, religion, sex (including pregnancy, lactation, childbirth or related medical conditions), sexual orientation, gender identity, age (40 and over), national origin or ancestry, physical or mental disability, genetic information (including testing and characteristics), veteran status, uniformed service member status or any other status protected by federal, state or local law (“Protected Characteristic”). Our commitment to equal opportunity employment applies to all persons involved in our operations and prohibits unlawful discrimination by any employee, including managers and co-workers.
