Similar Jobs
See allResearch Assistant
Care Access
US
Clinical Research
Patient Engagement
Data Management
Lead Clinical Research Associate
ProTrials
US
Clinical Research
Regulatory Compliance
Microsoft Excel
Clinical Study Operations Associate
Beacon Biosignals
US
Clinical Project Management
Organizational Skills
Communication
Regulatory Manager
Precision Medicine Group
US
Regulatory Affairs
Clinical Trials
Drug Development
Clinical Trial Liaison
Unknown
US
Clinical Research
Site Management
Stakeholder Engagement
Key Responsibilities:
- Lead clinical study strategies and evidence plans for regulatory submissions (FDA 510(k)/PMA, CE IVDR).
- Develop clinical protocols, claims, and evidence strategies with internal teams and external experts.
- Author and review clinical documentation and serve as a scientific liaison with regulatory bodies.
Requirements:
- Bachelor's degree in Life Sciences with 9+ years of clinical research experience (or advanced degree with less experience).
- Deep understanding of clinical study design in diagnostics or medical devices for US/EU markets.
- Strong ability to interpret and communicate scientific data and resolve complex trial issues.
Benefits:
- Annual salary range of $130,000–$150,000 with bonus eligibility.
- Fully remote work arrangement and comprehensive medical, dental, and vision insurance.
- Paid time off and 401(k) retirement plan included.
Partner Company
The company develops diagnostic products for the US and EU markets, focusing on generating robust clinical evidence for regulatory submissions. It maintains a remote-first culture with a collaborative, cross-functional environment and opportunities for scientific leadership.