Commissioning Agents, Inc.
  • - Quality Assurance
  • Raleigh, NC, USA
  • Excellent Benefits Package

Commissioning Agents, Inc. (CAI) is seeking motivated Regulatory & Compliance Consultants to support biotech and pharmaceutical projects across the country. This is a full-time position with competitive compensation and benefits.


CAI is a 100% employee-owned company providing commissioning, validation, start-up, and compliance consulting services to the biotech, pharmaceutical, medical device, food, cosmetic, and other mission critical facilities.  The company, headquartered in Indianapolis, IN was established in 1996 and has steadily grown to around 500 employees today with projects and clients in the US, Puerto Rico, Europe and Asia.  Projects range from $1000 to >$10 million and from one week to over four years.  We offer exceptional benefits, wage, professional development and training opportunities, with flexibility in a close-knit team environment.

The Regulatory and Compliance Consultant at Commissioning Agents, Inc. will provide regulatory and compliance guidance to domestic and international clients. This person will be responsible for preparing regulatory submissions for drugs, biologics and medical devices.

Requirements include:
BS in a science or engineering field or equivalent discipline

15 years' experience with FDA and internal regulatory submissions for drugs, biologics, and medical devices
Experience with project management is a plus
Excellent oral and written communication skills in English
Able to travel domestically and internationally if required
Able to work (paid) overtime
Able to work in the US without sponsorship


CAI has excellent benefits which include:

Company paid medical, disability and life insurance at almost no cost to the employee.

15 % Retirement contribution which includes company stock (we are 100% employee-owned)

24 days PTO and 5 sick days per year

Optional insurance (Dental, Vision, & Life) available at group rates

Support for continued professional education.

 

This job description is not all inclusive and you may be asked to do other duties.  CAI is an Equal Opportunity Employer.

 

For more information, and to apply, please see: http://commissioningagents.com/careers/  "Regulatory and Compliance Consultant".

Commissioning Agents, Inc.
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