Senior Regulatory Affairs Consultant

Location: Chicago, Illinois, USA
Salary: competitive
Job Type: Contract
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Do you have a strong background within Regulatory Affairs? Are you interested in working at a leading manufacturer of dental implants and systems? If you answered "Yes" to these questions, I have the perfect opportunity for you!

My client, leading manufacturer of dental implants and systems working with world renowned dental surgeons and universities for innovations and cutting edge design and technology, is actively searching for a Senior Regulatory Affairs Consultant to join its team in Chicago, Illinois. This will be structured as a 12 month contract. They are looking for a Senior Regulatory Affairs Consultant to provide hands-on regulatory affairs support for new product marketing approvals and renewals for existing products, including development of regulatory requirements/strategies and preparation of submissions.

Among others, this role will take on the following responsibilities:

  • Prepare worldwide submissions for new products and any product changes as needed to ensure timely approval for market release
  • Find, interpret, and prepare regulatory strategies and worldwide compliance requirements.
  • Documentation for all phases of regulatory submissions, including priority setting, requirements research, documentation gathering, submission writing, project schedules, approvals, renewals, and change orders.

The best candidates for this role will possess the following basic qualifications:

  • B.S. degree in Science or Engineering, related technical field
  • 5+ years of experience in the medical device industry
  • Thorough understanding of FDA and international submission requirements including how to comply with standards and regulations
  • Experience & knowledge of U.S., Canada, Europe, and Middle East regulations

The Senior Regulatory Affairs Consultant is an outstanding opportunity to take on immediate leadership and grow within a top notch organization, and Chicago, IL is a fantastic location!

If you are interested in learning more and/or applying, please reach out to me on the details below!

Sthree US is acting as an Employment Business in relation to this vacancy.

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