Director/Principal Specialist, Regulatory Affairs

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 p.huynh@proclinical.com.

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.