Senior Regulatory Affairs Lead - Global IVD Expert (Remote)

Integrated DNA Technologies; Boulder (CO); On-site; USD 110,000 - 135,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Integrated DNA Technologies is seeking a Regulatory Affairs professional to lead the creation of regulatory documents and ensure compliance with FDA and EU regulations. Located in Boulder, CO, this fully remote role requires a Bachelor's degree in a technical field and a minimum of 7 years' experience in a regulated environment.

The ideal candidate will have expertise in in vitro diagnostics, including global regulatory experience, and will work collaboratively to navigate regulatory landscapes. A comprehensive benefits package is offered, along with a competitive salary range of $110,000 – $135,000.

Qualifications

• Minimum 7 years of experience in a regulated environment.
• 4+ years of global regulatory experience related to in vitro diagnostics.
• Knowledge of U.S. FDA and EU IVD regulations.

Responsibilities

• Lead creation of regulatory documents for global approvals.
• Approve regulatory/quality documentation for new product development.
• Provide guidance on regulatory issues and compliance.

Skills

Regulatory submissions

Risk assessment

Collaborative facilitation

Analytical skills

Education

Bachelor’s degree in a technical field

Tools

ISO 13485

21 CFR Part 820

Job description

Integrated DNA Technologies is seeking a Regulatory Affairs professional to lead the creation of regulatory documents and ensure compliance with FDA and EU regulations. Located in Boulder, CO, this fully remote role requires a Bachelor's degree in a technical field and a minimum of 7 years' experience in a regulated environment.

The ideal candidate will have expertise in in vitro diagnostics, including global regulatory experience, and will work collaboratively to navigate regulatory landscapes. A comprehensive benefits package is offered, along with a competitive salary range of $110,000 – $135,000.