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Regulatory Affairs Co-Op (Fall Semester)

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Date: Apr 27, 2021

Location: Tewksbury, MA, US, 01876

Company: Corning

Requisition Number: 45844

 

Corning is one of the world’s leading innovators in materials science. For more than 160 years, Corning has applied its unparalleled expertise in specialty glass, ceramics, and optical physics to develop products that have created new industries and transformed people’s lives.

Corning succeeds through sustained investment in R&D, a unique combination of material and process innovation, and close collaboration with customers to solve tough technology challenges.

As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

 

Scope of Position:

As a Regulatory Co-Op, you will work as part of the Division Regulatory Affairs Department and working with group team members. You will work on solo and team projects to ensure CLS products meet necessary regulatory requirements (medical device, IVD, equipment, environmental). The areas of work can range from new product development, labeling reviews, research and assessment of regulatory changes, quality review and organization of regulatory documentation, compiling information for regulatory submissions, procedure & template development, post-market/vigilance. In this role you will assist, support and collaborate with the team to execute regulatory responsibilities.

 

Travel Requirements:

  • Negligible

 

Hours of work/work schedule/flex-time:

  • Standard business hours; Monday – Friday.

 

Required Education:

  • Currently enrolled in a graduate degree program in Regulatory Affairs.
  • GPA > 3.0

 

Required Skills:

  • Advanced skills with Microsoft Office Suite (Word, Excel, PowerPoint)
  • Strong problem solving, critical thinking and decision-making skills.
  • Able to work individually and as part of a group.

 

Desired Experience / Qualifications / Skills:

  • Basic understanding of medical device development or healthcare
  • Basic understanding of quality management system
  • Cell culture knowledge or exposure.
  • Exposure to FDA regulations.

 

Soft Skills:

  • Results oriented with a high commitment level.
  • Ability to handle multiple projects/tasks.
  • Motivated and a self-starter with independent learning style.
  • Effective communication & presentation skills (verbal and written).
  • Ability to work on diverse project team.
  • Able to build new business relationships with the team.
  • Positive, open and engaging and can be an effective member of a dynamic team. Dedicated and open to new ideas. Fast learner, with curiosity and flexibility

 

This position does not support immigration sponsorship.

 

We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status.

 

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.


Nearest Major Market: Boston