The Regulatory Affairs Intern will develop an understanding of the regulatory differences between US, European Union and Britain.

Essential Functions and Main Duties

• Works with the team to develop understanding of the different Regulatory Requirements for each country.
• Reviews the relevant requirements for software as a medical device from the FDA, the US Regulatory authority.
• Reviews the relevant requirements for software as a medical device. from the EMA the European Union Regulatory authority.
• Reviews the relevant requirements for software as a medical device from the MHRA the British Regulatory authority.
• Provides a comparative analysis on the relevant requirements from above.
• Participates in Intern program work events and presentations
• Adhere to all company policies, procedures, and business ethics codes.
• Duties may be modified or assigned at any time based on business need.

Qualifications

Education / Certification / Experience Required

• Currently enrolled in a Bachelor's/Master's degree program in Regulatory Compliance or related discipline.
• Level and compensation depends on location, experience, education and skills.

Competencies Required

• Must be able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English.
• Able to work effectively both independently and in a collaborative team environment.

Compensation

The anticipated range for this position is $18.00 to $21.00. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, experience and location.

Perks and Benefits

Visit our Career page to learn more about Perks & Benefits and working at Nihon Kohden America

Working Conditions

Schedule: The regular hours for this internship position are 8:00 a.m. to 5:00 p.m., Monday – Friday, unless otherwise stated by the department manager. Holiday, weekend, and evening work hours may be required. Regular hours may vary due to the needs of the organization or department and are subject to change at any time at the Company's discretion.

Physical: Generally may require some reaching, bending, stooping, squatting, crawling, kneeling, pushing, pulling, lifting, carrying up to 20 pounds, finger dexterity, repetitive motions, standing, walking, sitting, hearing, visual acuity, color vision, and 2-way written/verbal communication in English. More specific details may be provided as needed or requested.

Travel: None

Access to Customer Sites: Not Required

Nihon Kohden America's official EEO policy statement follows. In keeping with this policy, Nihon Kohden America will continue to recruit, hire, train, and promote into all job levels the most qualified persons without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, marital status, genetic information, disability, or because he or she is a protected veteran. Similarly, Nihon Kohden America will continue to administer all other personnel matters (such as compensation, benefits, transfers, layoffs, company-sponsored training, education, tuition assistance, and social and recreational programs) in accordance with Company policy. Nihon Kohden America bases employment decisions on objective standards as much as possible in the furtherance of equal employment opportunity.

If you have a disability under the Americans with Disabilities Act or similar law, or you require a religious accommodation, and you wish to discuss potential accommodations related to applying for employment at Nihon Kohden, please contact Human Resources.