Senior Regulatory Affairs Lead - Global IVD Expert (Remote)

Integrated DNA Technologies; New York (NY); Remote; USD 110,000 - 135,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

Paid time off

401(k)

Job summary

Integrated DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance within life sciences and diagnostics. You will lead the creation of regulatory documents and provide guidance on product development while collaborating with international teams.

The ideal candidate has at least 7 years of experience in a regulated environment, specifically in in vitro diagnostics. This position is fully remote, offers a salary range of $110,000 – $135,000, and includes benefits like 401(k) and medical insurance.

Qualifications

• Minimum 7 years of experience in a regulated environment, with 4+ years in global regulatory for in vitro diagnostics.
• Knowledge of U.S. FDA and EU IVD regulations; experience in PMA, de novo, 510(k) submissions.
• Experience with ISO 13485, IVDR, and 21 CFR Part 820 relevant to product development.

Responsibilities

• Lead creation of regulatory submissions and documentation for global product approvals.
• Provide guidance on regulatory/quality documentation for new product development.
• Assess risks associated with regulatory issues and ensure compliance with regulations.

Skills

Regulatory documentation creation

Regulatory assessment

Risk management

Analytical skills

Collaboration

Education

Bachelor’s degree in a technical field

Job description

Integrated DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance within life sciences and diagnostics. You will lead the creation of regulatory documents and provide guidance on product development while collaborating with international teams.

The ideal candidate has at least 7 years of experience in a regulated environment, specifically in in vitro diagnostics. This position is fully remote, offers a salary range of $110,000 – $135,000, and includes benefits like 401(k) and medical insurance.