Senior Director, Regulatory Affairs - HYBRID

Senior Director, Regulatory Affairs - Permanent - Hybrid

Proclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a cutting-edge AI company. This is a permanent role with the opportunity to work hybrid in California.

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.
• Advanced interpersonal skills and a demonstrated ability to manage conflict situations.
• Strong negotiation skills and proven effective collaboration with US FDA or other regulatory agencies.
• BS in technical discipline related to software engineering or medical physics required. Master's Degree in Regulatory Science or Equivalent preferred.
• Previous Success in registering software as a medical device (SaMD, SaaS).
• Knowledge or experience in the following: US 510K, MDR/CE, STED, etc.
• Comfortable working in a high growth / start up environment.
• International regulatory filing experience, preferably in Asia and/or Europe.
• Ability to be "hands on" in registration and filing processes and work within a dynamic start up environment.

The Senior Director, Regulatory Affairs will:

• Direct the activities of the Product Development team, which is comprised of scientists and engineers responsible for the development and delivery of the instrument system with associated control software, data analysis software, microfluidic chips, reagents, and consumables.
• The Senior Director, Regulatory Affairs (SDRA) will lead regulatory strategies for new medical device 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 WW. The SDRA will work closely with R&D and Clinical to drive validation strategies and clinical protocols.
• 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.
• Interface externally with regulators and others as a credible, influential, respected thought leader and company spokesperson. Represent to regulators before, during and after product development and commercial introduction.
• Complete regulatory submissions and compliance assessments
• This position does not have direct reports.
• Perform any other related activities assigned by reporting manager.

Compensation:

$225,000 annually

If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at (+1) 646-367-2908 or n.walker@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.