Careers in MedTech

Job Title

Clinical & Regulatory Affairs Manager

Company

Piccolo Medical Inc

Description

About Piccolo Medical
Piccolo Medical is an early-stage medical device start-up spun out of TheraNova LLC, San Francisco’s premier medical device incubator. Piccolo has developed a novel catheter navigation technology that has been FDA cleared and is currently in human trials today focused  on expanding our indications. We plan to close our Series B financing and execute on a commercial launch in the coming year. We have a small and very experienced R&D team looking to grow. We are focused, hard-working and we need your help!

Job Summary
Responsible for the overall planning and direction of clinical and regulatory activities. Develops and implements strategies with the goal of expanding our indications and product offerings with a significant focus on health economics.

Primary Responsibilities
• Lead and execute multicenter clinical studies with the SmartPICC system
• Design and execute the investigational plans for post-market studies, non-significant risk
studies, and marketing studies.
• Develop clinical strategy to support commercialization efforts focused on indication
approvals/expansion and health economic outcomes research (HEOR)
• Hire, train, and supervise clinical staff and regulatory consultants
• Plan, schedule and direct clinical activities and assist with training programs
• Approve quality documents as required by our quality system
• Develop and implement regulatory strategies (with regulatory consultant) for the earliest possible approval of regulatory submission ensuring compliance with the FDA
• Prepare and submit applications, inquiries and reports to IRBs, FDA, and Notified Bodies
• Submit supplements and amendments to update registered product information
• Monitor and update domestic and international registration requirements through reviews of publications, seminars, and direct communication with outside regulatory personnel.
• Handle budget requirements and monitor project and program costs

Published
November 24, 2021
Location
San Francisco, CA, CA
Category
Medtech  
Job Type
Only registered members can apply for jobs.
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