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Engineering
Regulatory & Compliance
Healthcare IT
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Information Technology
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Regulatory & Compliance
Engineering
Healthcare IT
Regulatory Affairs Consultant

 

At Madison Technical, we provide a total regulatory compliance and validation consulting service.

Our regulatory affairs consultants are expected to have skills and experience in ensuring that medical device manufactures, healthcare organizations, and companies in the pharmaceutical industry comply with government regulations and laws relevant to the client’s products. This would include the ability to:

• Prepare, review and assemble document submissions to global regulatory authorities, including new      applications,   registration, renewals, product listings and investigational applications.
• Coordinate with relevant agencies to resolve issues and speed up approvals.
• Setup and implement regulatory standard operating procedures.
• Handle day-to-day regulatory operations.
• Provide expert advice on regulatory strategy.

Our regulatory affairs consultants should have the necessary skills to provide the following services to our clients:

• Post Approval Reports
• Biologics License Application (BLA) Submissions
• Regulatory Agency Interaction
• Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs
• Drug Master Files (DMFs)
• NDA/ANDA Submissions

As a Madison Technical consultant, you should be able to work well as part of skilled team, be able to train others efficiently and have excellent problem-solving skills.

We have a successful track record in securing engagements and offer our regulatory affairs consultants an exciting and rewarding consulting partnership.

Madison Technical has a worldwide presence with clients in 23 countries and offices in the U.S., Puerto Rico, Europe, and Asia. We are the world’s largest specialized technical staffing company.

Madison Technical is looking for qualified consultants to join our team. If you are a subject matter expert or skilled consultant seeking quality engagements, we invite you to partner with the global leader in specialized technical staffing services.

For information on why Madison Technical is the right career choice for you contact us today.

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(800) 206-7956