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Featured Employers
Spring 2021 Regulatory Affairs Co-Op
Company: Thermo Fisher Scientific
Location: Kalamazoo, MI
Employment Type: Co-op
Date Posted: 12/02/2020
Expire Date: 02/02/2021
Job Categories: Science
Job Description
Spring 2021 Regulatory Affairs Co-Op
Regulatory Affairs Intern

Customers throughout the globe rely on our extensive range of products and services—from next-generation instruments to everyday lab essentials to life-saving medicine. If you desire to be a part of a world-class team, Thermo Fisher Scientific can provide you with the opportunity to work in manufacturing to produce products that enable our customers to make the world healthier, cleaner and safer. Operational Excellence in Manufacturing & Production is carried out by dedicated, team-oriented professionals who want to make a difference.

Summary of Role

Regulatory Affairs intern will be involved in daily functional goals for strategic planning, review and interpretation of new guidelines (i.e. submissions and filing), procedures and work instructions, local assignments with FDA submission needs.
Assist in the formation of national product commercialization process and corporate initiatives, if applicable.
Creating standard work documents (i.e. standard operating procedures, work instructions). Assess gaps in RA and QA processes. Evolve into strategic planning and large project mapping. Work on registration submissions and filings.
Complete gap assessment of US RA processes and provide a plan.
Complete RA work instruction for Product Registration in the US.
Complete proposed process for Product Commercialization Process/Global Product Registration

Qualifications:
Students who are completing a Bachelor’s or Masters degree in science or engineering
Preferred majors: Focus in Medical Device or Pharmaceutical Regulatory Science or Regulatory Affairs (i.e. masters program)
Strong desire and motivation to develop a career in quality/manufacturing/operations
Related work or internship experience preferred
Strong leadership and team building skills
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
Qualifications & Requirements
Qualifications:
Students who are completing a Bachelor’s or Masters degree in science or engineering
Preferred majors: Focus in Medical Device or Pharmaceutical Regulatory Science or Regulatory Affairs (i.e. masters program)
Strong desire and motivation to develop a career in quality/manufacturing/operations
Related work or internship experience preferred
Strong leadership and team building skills
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status
Contact Information
Company Name: Thermo Fisher Scientific
Website: https://jobs.thermofisher.com/globa...
Company Description:
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.
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