Boston Scientific Regulatory Affairs Intern 

United States, Minnesota, Maple Grove 

716369814

Benefits:

• Corporate housing & relocation assistance or living stipend available for those who meet eligibility requirements
• Half-day Fridays all through the summer
• Free on-campus fitness center & group fitness classes
• Events throughout the summer include Intern social outings, volunteer day, ice cream & BBQs at the park, opportunities to learn about other BSC sites/departments and network cross-functionally with leadership and peers, and more!
• Casual, comfortable dress code and inclusive company culture

Interns working in Regulatory will support many of our global commercial products by working on regulatory submissions, upholding global regulatory requirements, maintaining internal regulatory file documentation and supporting continuous improvement activities.

Key Responsibilities:

• Learn regulatory requirements to commercialize medical devices
• Support EU MDR Technical Documentation updates
• Prepare and submit regulatory submissions (potential example - FDA PMA supplement for a manufacturing change)
• Use regulatory advocacy to influence the regulatory process
• Collaborate with cross functional partners to support product and manufacturing changes and draft assessments regarding compliance with applicable regulations

Qualifications:

• Current Bachelor's student in your Junior or Senior year or grad student. Must have at least one semester of school left post-internship to qualify.
• Pursuing degree in Science or Healthcare related field (Scientific, Engineering, Math, Communication, Nursing, and Allied Health Psychology majors preferred) or Master’s degree in Regulatory, Clinical Affairs, or Public Health
• Related work/intern experience in medical areas
• Must have authorization to work in the United States without restriction.
• Must possess excellent written and verbal communication skills
• Display basic understanding of data collection, analysis and interpretation tools, techniques and outcomes
• Confident presentation skills preferred
• Ability to translate technical information into clearly written documents
• Quick learner, self-motivated, independent worker
• Strong computer, word processing, PowerPoint and database skills

Quality System Requirements:

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.