Senior Regulatory Affairs Leader
Medical Robotics : Structural Heart
Class III Original PMA Submissions
Hybrid : Bay Area : Full Time Direct Hire
Our office has partnered with a transformational new Bay Area medtech start-up utilizing advanced robotics to combat structural heart disease.
Our client is developing a revolutionary new robotic-assisted transcatheter valve replacement platform empowering physicians with precision control and stability improving patient outcomes on traditional heart valve procedures.
With a substantial recent financing round alongside a world-class team of cardiovascular and surgical robotic SMEs, Capstan has an opportunity to deliver innovation that will completely redefine transseptal-based heart valve procedures.
Currently seeking a new Senior Regulatory Affairs Leader to spearhead all FDA Pre-Market Approval submission activities as well as post-market supplements and international product registrations
This is a critical component toward Capstan Medical’s future operations leading the organization through its upcoming IDE award, and fostering a clear and collaborative communication line with the FDA to ensure a successful PMA submission and approval.
Ideally seeking a background in cardiovascular solutions however open to alternative medical implantables, robotics, and / or class III medical electronics with prior successful PMA approval.
Senior Regulatory Associate US Regulatory Affairs
A company is looking for a Senior Associate in US Regulatory Affairs. ...
Vice President/Senior Vice President, Regulatory Affairs
Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance. Lead Regulatory Affairs and Quality Assurance functions. Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients. Manage all aspects of Regulatory su...
Senior Counsel - Litigation Regulatory Affairs
A company is looking for a Senior Counsel for Litigation, Regulatory Affairs, and Procurement Support. ...
Senior Director, Regulatory Affairs Advertising and Promotion
Senior Director, Regulatory Affairs - Advertising and Promotion. They are looking for a Senior Director of Regulatory Affairs, Ad/Promo to join their team to support the commercialization of their late-stage programs. You will define regulatory strategies for the company's commercial and corporate c...
Regulatory Affairs Director - Global Regulatory Leader
A company is looking for a Regulatory Affairs Director - Global Regulatory Leader in General Medicine/Cardiovascular. ...
Director/Senior Director, Regulatory Affairs Advertising and Promotion Boston, M
The base range for a Director, Regulatory Affairs is $212,000 - $245,000 and Senior Director, Regulatory Affairs is $260,000 - $295,000 per year. Reporting to the Head of Regulatory Affairs, this role will lead the development of processes and policies and establish commercial regulatory infrastruct...
Senior Associate Regulatory Affairs
Senior Associate Regulatory Affairs; Thousand Oaks, CA; Lead the organization and preparation of the CMC (Chemistry, Manufacturing, and Controls) sections of global annual notifications to meet regulatory requirements. ...
Senior Regulatory Affairs Specialist
ABOUT THE ROLE Senior Regulatory Affairs Specialist will assist in regulatory submissions, interpret regulations, and provide regulatory guidance. Senior Regulatory Affairs Specialist to join our dynamic team. Perform additional duties as assigned, contributing to the team's success WHAT YOU'LL NEED...
Regulatory Affairs Senior Specialist, Hybrid
Regulatory Affairs Specialist (Senior Level). We are seeking a Regulatory Affairs Specialist (Senior Level) to ensure company compliance with US FDA 510(k), Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, and ISO 13485. Monitor Regulat...
Senior Regulatory Affairs Specialist - Vascular (on-site)
As an individual contributor, the function of a Senior Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. Senior Regulatory Affairs Specialist. Understand, investigate and evaluate regulatory history...