Clinical Trials Scientist - Diagnostics & Regulatory

Beckman Coulter Diagnostics; Charlotte (NC); On-site; USD 120,000 - 165,000; Full time

Benefits offered by this job

Bonus program

Benefits package

Remote-friendly

Job summary

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead clinical study designs and evidence strategies for global submissions in US and EU markets. This role drives regulatory alignment and collaborates across R&D, Regulatory, and Medical Affairs to advance product clearance.

You will mentor scientists, review study reports, and maintain expertise in evolving regulatory standards while supporting Danaher Diagnostics. Remote-based with potential onsite in MN.

Qualifications

• Bachelor’s degree with 9+ years in clinical research, US/EU trials preferred.
• Master’s degree with 12+ years in clinical research is acceptable.
• Doctoral degree with 4+ years in clinical research is acceptable.
• Strong ability to review data, protocols and reports; communicate clearly.

Responsibilities

• Design clinical studies and evidence strategies for global regulatory submissions (FDA/CE).
• Act as scientific liaison with regulatory bodies and key opinion leaders.
• Collaborate across R&D, Regulatory, Medical Affairs, Quality and Commercial teams.
• Author and review clinical/regulatory documents to support clearance and commercialization.
• Mentor junior scientists and stay current with evolving regulatory standards.

Skills

Clinical study design

Regulatory liaison

Cross-functional collaboration

Scientific communication

Data interpretation

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

Doctoral degree in Life Sciences

Job description

Beckman Coulter Diagnostics is seeking a Principal Clinical Scientist to lead clinical study designs and evidence strategies for global submissions in US and EU markets. This role drives regulatory alignment and collaborates across R&D, Regulatory, and Medical Affairs to advance product clearance.

You will mentor scientists, review study reports, and maintain expertise in evolving regulatory standards while supporting Danaher Diagnostics. Remote-based with potential onsite in MN.