VP, Quality and Regulatory Affairs

VP, Quality and Regulatory Affairs

Posted Mar 20 2019

San Francisco, New York

Full time

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What will you do

About the role
The VP Quality and Regulatory Affairs (QA/RA) will proactively develop, lead and drive the execution of global regulatory strategy and quality oversight for Current Health. They will provide operational leadership for quality/regulatory systems and processes to ensure that our wearable, its peripherals and our health care platform conforms to established internal and external standards and guidelines. Most importantly, it is a critical role in building the best possible product that saves people’s lives.
The position is responsible for leading the company’s global regulatory and quality functions for product approvals, registrations and compliance to worldwide regulations. It will also be the primary contact with public health agencies that affect our product approval for use both in clinical settings and at home e.g., Food and Drug Administration (FDA), Notified Bodies and other state agencies.

Core Responsibilities
• Serve as a key and active member of the leadership team, working collaboratively to ensure regulatory and quality objectives are aligned with our strategic direction.
• Develop and mentor the Quality Assurance and Regulatory Affairs team.
• Creation and implementation of regulatory strategies and processes to inform worldwide approvals.
• Provide regulatory guidance to our cross-functional team regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products
• Oversee preparation and filing of all regulatory documents with the FDA and international regulatory agencies, within applicable regulations and guidelines.
• Develop and maintain external relationships with relevant opinion leaders and regulatory officials.
• Leads corporate regulatory strategies related to new product development and prepares documentation for worldwide regulatory government submissions for obtaining Premarket 510(k) clearances, Premarket Application approvals, CE-marking and international device licenses.
• Provide counsel, training and interpretation of FDA and global regulatory requirements to all members of the team.
• Responsible for strategic leadership of our Quality Management System (QMS).

About you

  • Experience of working in an early Series A stage company and pragmatically contributing to overall strategic direction and growth.
  • Expert experience in medical device regulation and quality management systems. Including in software quality management and regulation e.g. Software as a Medical Device (SaMD)
  • Extensive prior experience working with the MHRA, notified bodies and the FDA
  • Applied knowledge of ISO 13485, FDA CFR 820, MDSAP, MDD and MDR; insights into emerging standards and regulations
  • Experience of ISO 27001, GDPR and HIPAA is a plus
  • Experience hosting and managing third party audits (e.g. FDA, Notified Bodies and customers).
  • Practical experience of merging Agile development and regulatory practices facilitating innovation while ensuring overall quality and regulatory compliance.
  • A BSC degree or equivalent in a Life Sciences field would be ideal
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