San Francisco, United Kingdom
about 1 year ago
Are you looking to join an innovative Series-A Software Medical Devices company based in the Bay Area? If you’re an experienced Regulatory Affairs and Quality Assurance individual and want to head up the US QARA operations for their healthcare software product, then this is for you!
The VP Quality and Regulatory Affairs will proactively develop, lead and drive the execution of global regulatory strategy and quality oversight.
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.
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.
- 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).
- 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. Including:
- writing & submitting FDA Pre Submission, 510k’s and CE Technical Files
- FDA part 11 compliance for computer system validation
- Gaining CE marking
- 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
- You are flexible and can learn on the job quickly
- You enjoy solving problems and making a difference
- It is important you can pragmatically balance quality with a fast-paced schedule
- You are a good team player, ready to help, debate, compromise and work together with experience in coaching and developing people
- You are comfortable working, prototyping and delivering incrementally, adapting based on customer needs and technical difficulties, always with the user in mind
- You always look at the big picture
- You are extremely detail-oriented with strong organisational skills and high quality standards
- You have the ability to develop strategic goals and objectives from knowledge base and understanding of a customer’s business.
- You have the ability to manage changing conditions, processes and approaches and lead the company through change effectively.