Quality Assurance & Regulatory Affairs Manager

1QBit

Your Role
As Quality Assurance & Regulatory Affairs Manager, you will responsible for the development,
implementation, and management of the company’s Quality Management System as well as its
regulatory strategies and submissions. This role is accountable for regulatory and quality leadership
across the business within a highly regulated medical devices environment. Your success in this position
will help us to bring AI-based medical devices to market and empower physicians to more effectively
provide patient care.

What You’ll Do
• Establishes, implements, and maintains the company’s Quality Management System to comply with
applicable regulations and standards for medical devices.
• Provides quality and regulatory affairs subject-matter expertise and advice to the business.
• Collaborates with cross-functional teams to develop strategies, programs and processes to meet
business objectives and ensure compliance with applicable standards and regulations.
• Prepares pre-market regulatory submissions and communicates with regulatory authorities to obtain
market authorization.
• Investigates and resolves compliance matters, questions, or complaints and submits reports to
regulatory authorities, as required.
• Manages audit program and conducts internal audits and supplier audits, as necessary.
• Analyzes and communicates to senior management any significant proposed, new or changing
regulatory requirements and standards impacting the business.
• Leads regulatory authority and notified body audits and inspections on behalf of the company.
• Educates, trains, advises, and coaches employees to ensure effective implementation of the QMS,
and compliance with applicable standards and regulations.

What You’ll Bring
• Bachelor’s degree or equivalent experience in a relevant field
• Minimum 5 years experience in Quality and Regulatory Affairs in healthcare or life sciences industry.
Medical device industry preferred.
• Proven experience with global medical device regulations and standards, including ISO13485,
ISO14971, Health Canada and US FDA requirements.
• Knowledge of Software as a Medical Device (SaMD) and agile development methods preferred.
• Strong analytical and critical thinking skills
• A keen eye for detail and a results-driven approach
• Outstanding communication skills
• Excellent organizational and leadership skills

Who We Are
The Healthcare team is a fast-paced group of healthcare experts, machine learning scientists, and
software developers that passionately works to develop solutions that empower frontline care workers
with scalable intelligent technologies. By partnering technology with medicine, and doing the scientific
work necessary, we’re determined to establish a new standard in the way that diagnostics and treatment
are performed worldwide.

About 1QBit
1QBit is dedicated to solving the world’s most intractable challenges by recasting problems to harness
the power of quantum computing. We identify demanding industry problems and apply breakthroughs in computation to machine intelligence and optimization science to build software that allows applications to continually benefit from advances in both quantum and classical hardware.

Why work at 1QBit? You will have a chance to be part of a diverse and collaborative team and enjoy perks including: eligibility to take part in our Options Plan, full health and wellness benefits, extra long-long weekends, plenty of social events, and flexible work from home options.

To Apply please contact Sohee Kim at sohee.kim@1qbit.com