Base: $99,300.00 – $198,700.00; bonus/equity: not ...
Onsite
Clinical trial design
Regulatory submissions
Scientific leadership
Design clinical trials and studies in collaboration with internal and external stakeholders to support device premarket approval (PMA) applications and premarket notification submissions (510(k)) to the FDA
Job Summary
Design clinical trials and studies in collaboration with internal and external stakeholders to support device premarket approval (PMA) applications and premarket notification submissions (510(k)) to the FDA.
Lead the generation of study-related documents, including clinical study protocols, case report forms, clinical study reports, and informed consent forms, and generate documents to support regulatory submissions.
Abbott offers career development, medical coverage, an excellent retirement savings plan, tuition reimbursement, and is recognized as a great place to work globally.
Matching Summary
Design clinical trials and studies in collaboration with internal and external stakeholders to support device premarket approval (PMA) applications and premarket notification submissions (510(k)) to the FDA.
Salary
Base: $99,300.00 – $198,700.00; Bonus/Equity: Not specified; Benefits: Medical coverage, retirement savings plan, tuition reimbursement
Skills & Requirements
Must-have
Clinical trial design
Regulatory submissions
Scientific leadership
Data analysis and presentation
Publication strategy development
Nice-to-have
Cross-functional team collaboration
Mentoring junior team members
Process optimization
New idea generation
Key Requirements
Bachelor’s Degree in related field or equivalent
Minimum 8 years of related work experience
Comprehensive knowledge of a particular technological field