Radiometer · 4 hours ago
Senior Regulatory Affairs Scientist
New Brighton, MN
Full-time
Remote
Senior Level, Lead/Staff
$120K/yr - $145K/yr
10+ years exp
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Responsibilities
Provide regulatory guidance through all phases of a project, research and development, pre-clinical and clinical testing, and final data analysis and write specific sections of regulatory submissions
Provide regulatory and scientific guidance and mentoring of SMEs in different functional areas
Advise on regulatory strategy and submissions based on the latest regulatory bodies thinking and guidelines (e.g. FDA, EU, ICH, etc.)
Assist the project teams in developing and interpreting valid scientific evidence to demonstrate that the device meets the requirements and expectations of regulatory bodies on safety, efficacy, quality and performance.
Qualification
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Required
Bachelor’s degree or master's in a scientific field (engineering, pharmacy, biology, biochemistry, biotechnology, medical technology, or similar)
At least 10 years’ combined work experience with Regulatory Affairs and 3 years' experience in a scientific field
Knowledge and experience in global IVD/MD regulations, quality standards such as ISO 13485, US FDA 21 Part 820, IVDR/MDR, design control, risk management, etc.
Regulatory experience with taking a product from development through regulatory approval in US and life cycle management, including interactions with regulatory bodies such as FDA and notified bodies
Good understanding of statistical methods and analysis
Preferred
Experience with giving both scientific and regulatory input to claims, test plans, test protocols (non-clinical and clinical)
Detailed knowledge about other technical or SME areas such as software, usability, stability, clinical, post market surveillance
Benefits
Paid time off
Medical/dental/vision insurance
401(k)
Company
Radiometer
When life takes an unexpected turn, Radiometer’s technology and solutions enable health care professionals to make informed diagnostic decisions to improve patient care.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Jesper Kjær Hansen
CIO and VIce President
Company data provided by crunchbase
