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Proclinical Staffing
Denver, CO, United States
Director/Principal Specialist, Regulatory Affairs - Permanent - Denver, CO Proclinical is seeking a Director/Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI/ML with their location in the Denver, CO area. Primary Responsibilities: Lead regulatory strategies for new m
Job Source: Proclinical StaffingConfidential
Denver, CO, United States
Senior Director, Regulatory Affairs About the Company International labelling organization based in Los Angeles Industry Retail Type Privately Held About the Role The Senior Director, Regulatory Affairs will be responsible for developing and managing labeling for products worldwide as well as overseeing the strategic regulatory leveling HA intera
Job Source: ConfidentialConfidential
Denver, CO, United States
Executive Director, Regulatory Affairs About the Company Pioneering developer & manufacturer of innovative therapeutic medicines Industry Biotechnology Type Public Company Founded 1980 Employees 10,001+ Categories Biotechnology Biotechnology and Pharmaceuticals Biotech Health Care Pharmaceutical Pharmaceuticals Academic Research Manufacturing Genom
Job Source: ConfidentialEurofins USA Clinical Diagnostics
Centennial, CO, United States
Job Description Job Description Company Description Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO
Job Source: Eurofins USA Clinical DiagnosticsEurofins Agro NL
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Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent ma
Job Source: Eurofins Agro NLImbria Pharmaceuticals
Denver, CO, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell’s ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsDanaher Corporation
Denver
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whethe
Job Source: Danaher CorporationDanaher Corporation
Denver, CO, United States
Danaher Corporation Senior Director Global Regulatory Affairs in Denver , Colorado At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and service with the ideal operating environment to lay the groundwork fo
Job Source: Danaher CorporationDenver, CO, United States
Director/Principal Specialist, Regulatory Affairs - Permanent - Denver, CO
Proclinical is seeking a Director/Principal Specialist, Regulatory Affairs for a rapidly growing and exciting medical technology company specializing in SaMD with AI/ML with their location in the Denver, CO area.
Primary Responsibilities:
In this role, you will lead regulatory strategies for new medical technology products and support numerous 510(k) applications.
The position will be based at their Colorado site in a hybrid work schedule.
Skills & Requirements:
Accomplished Regulatory professional with extensive experience forged within the Medical Devices sector dealing with the major regulators (FDA, EU NBs, etc.).
8+ years of experience in Regulatory Affairs with SaMD, SaaS, or embedded software products. Preferably with AI/ML and/or imaging product experience
Solid basis in scientific approach and an ability to deal with in-depth technical information from a variety of disciplines; foster a high degree of scientific credibility with regulatory agencies and internal stakeholders.
Excellent oral and written communication skills. Written skills include 510(k) and other regulatory filings worldwide.
Previous Success in registering software as a medical device (SaMD, SaaS).
The Director/Principal Specialist, Regulatory Affairs will:
Lead regulatory strategies for new medical technology products/business areas using advance technologies including AI/ML in the clinical imaging and workflow markets; these indications provide improved clinical outcomes for thousands of patients worldwide. You will work closely with R&D and Clinical to drive validation strategies and clinical protocols.
Contribute to continual development of the company’s regulatory strategy in support of company objectives.
Establish and maintain industry-leading practices and documentation for regulatory and other excellence in medical device applications including SaMD/SaaS applications.
Support, in conjunction with the QA group, the development/refinement of internal systems for regulatory compliance in alignment with the company’s evolving growth and operating phases.
Plan and execute successfully and efficiently all FDA and other regulatory and compliance activities related to the assigned areas of responsibility.
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or [email protected] .
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
Email Alert for Director/Principal Specialist, Regulatory Affairs jobs in Denver, CO, United States
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