Vice President of Global Regulatory Affairs
Confidential
Vice President of Global Regulatory Affairs
About the Company
Innovative designer & manufacturer of surgical robotics
Industry
Medical Devices
Type
Privately Held, VC-backed
Founded
2009
Employees
501-1000
Funding
$101-$200 million
Categories
- Biotechnology
- Health Care
- Medical Device
- Robotics
- Medicine
Specialties
- surgical robotics
- healthcare
- and manufacturing
About the Role
The Company is seeking a Vice President of Global Regulatory Affairs to lead the development and execution of a comprehensive regulatory strategy for its complex surgical robotics portfolio, with a focus on oncology applications. The successful candidate will be responsible for both strategic and operational regulatory initiatives, including driving regulatory submissions and approvals, global market entry, and post-market compliance. This role requires a proven track record in guiding cross-functional teams to regulatory success in multiple global jurisdictions, as well as a deep understanding of FDA regulations, ISO standards, and EU MDR. The ideal candidate will have at least 20 years' of progressive regulatory affairs experience in the medical device industry, with a strong background in complex device ecosystems and experience in robotic-assisted surgical devices. Key responsibilities for the Vice President of Global Regulatory Affairs include developing and maintaining an agile global regulatory infrastructure, overseeing US and global regulatory strategies, and providing expert guidance on regulatory pathways for new technologies and oncology-related device submissions. The role also involves cross-functional collaboration, team development, and management, and ensuring global compliance with regulatory standards. The candidate should be a recognized leader in the regulatory community, with a network of industry and agency contacts, and possess exceptional team-building abilities. A BS/BA in a relevant scientific, engineering, or medical discipline is required, with an advanced degree strongly preferred. The role demands a leader who is adept at balancing risk management with the need for timely and innovative product development, and who can influence stakeholders at all levels.
Hiring Manager Title
SVP of Global RAQA
Functions
- Legal
- Operations
$266.73k - $313.8k
...That Awaits You: As PROCEPT BioRobotics’ continues to evolve and expand its global footprint, we seek a world-class regulatory executive to serve as Vice President (VP) of Global Regulatory Affairs (RA). This role will report into the SVP of Global RAQA. This leader will...SuggestedFull timeLocal areaPROCEPT BioRobotics
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$250k
job summary: Join Our Client, an innovative global leader, as VP of Global Facilities in San Jose, CA. Requires 15+ yrs hands-on facilities... ...,Photonics,project management,Capital project management,regulatory compliance,renovation,risk management,risk mitigation,safety...Permanent employmentTemporary workWork experience placementWork at officeLocal areaWorldwideRelocation package- ...Vice President, Deputy General Counsel About the Company Innovative provider of business... ...and engineering teams, ensuring regulatory compliance in product updates and marketing... ...have a deep understanding of U.S. and global privacy and data protection laws, as well...
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