Global Clinical Regulatory Specialist: CERs & PMCF

Terumo Blood and Cell Technologies; Lakewood (CO); On-site; USD 109,000 - 136,000; Full time

Job summary

Terumo Blood and Cell Technologies is seeking a Global Clinical Regulatory Specialist to lead CERs and PMCF documentation, gather data from literature and safety sources, and coordinate cross-functional reviews. The role involves authoring Clinical Evaluation and PMCF plans and reports, and ensuring compliance with regulatory requirements across multiple regions.

The candidate will manage systematic literature reviews, risk management inputs, and regulatory submissions while collaborating with

Qualifications

• Graduate degree in scientific or regulatory field.
• 5 years' experience in clinical regulatory writing and literature reviews.
• Experience with CERs, PMCF, SLRs and regulatory guidelines.

Responsibilities

• Lead CER and PMCF development with cross-functional teams.
• Conduct systematic literature reviews and data extraction.
• Prepare Clinical Evaluation and PMCF documentation.
• Coordinate with regulatory and quality teams for submissions.
• Monitor literature for safety concerns and product portfolio.
• Ensure compliance with global regulatory requirements.

Skills

Leadership

Interpersonal skills

Project management

Regulatory knowledge

Clinical writing

Literature appraisal

Data analysis

Presentation skills

Microsoft Office

Cross-functional teamwork

Education

MS or PhD in science

Tools

Regulatory databases

Job description

Terumo Blood and Cell Technologies is seeking a Global Clinical Regulatory Specialist to lead CERs and PMCF documentation, gather data from literature and safety sources, and coordinate cross-functional reviews. The role involves authoring Clinical Evaluation and PMCF plans and reports, and ensuring compliance with regulatory requirements across multiple regions.

The candidate will manage systematic literature reviews, risk management inputs, and regulatory submissions while collaborating with