Regulatory & Quality Affairs Manager

Regulatory Affairs & Quality Manager (fully remote)

About Hyfe

Hyfe is the global leader in cough. We deliver cough-monitoring and analysis services for thousands of researchers, pharma, physicians and patients across the world.

From remote-patient-monitoring in chronic care management, to digital biomarkers for clinical trials, we bring precision medicine and personalized approaches to respiratory health.

Hyfe’s AI models are trained on the world's largest database of 25B+ data points collected from 160+ countries. Hyfe has also been validated in 46+ research trials across indications including chronic cough, asthma, COPD, congestive heart failure and covid.

We've built a great team that prioritizes outcomes over inputs, constant learning and mutual respect. Our ~30 person team, based across 14 countries to date, brings together brilliant scientists, clinicians, engineers and commercial experts to build an exciting fast-growing business.

Your Mission

We’re seeking a highly motivated Regulatory & Quality Affairs Manager. You’ll utilize your impressive skills & expertise to lead on regulatory strategy and submissions, drive quality system improvements across the organization, and look ahead to our reimbursement strategy. You’ll build on our success to date in putting compliance and regulatory approvals at the heart of our company’s growth whilst retaining the nimbleness and speed of a small organization.

Responsibilities will include:

• Lead on future regulatory submissions to the FDA, plus other jurisdictions such as the EU.
• Build and maintain good relationships with regulatory authorities
• Select and manage 3rd parties to support regulatory progress, including external consultants, laboratories, and CROs
• Maintain continuous improvement of Hyfe’s quality systems, including ISO certifications, taking over key compliance roles as appropriate
• Be the internal expert on the regulatory status & needs of our suite of products from medical device, to software, to consumer app
• Define our future reimbursement strategy and develop our evidence for payers & other stakeholders

Must-haves

• Minimum 5 years experience in Regulatory Affairs.
• Up to date experience of regulatory submissions to the FDA, preferably leading submissions, but certainly with deep involvement across all aspects
• Experience maintaining ISO standards, particularly ISO27001 and ISO13485
• Experience managing 3rd party suppliers such as consultants and laboratories
• An understanding of what it is like working in a small company, and enthusiasm for retaining nimble ways of working
• A positive can-do attitude and a desire to be constantly learning

Nice-to-haves

• Previous experience leading regulatory submissions and reporting outside the United States, including CE mark, UKCA and Health Canada applications
• Experience developing reimbursement strategies in the US (or outside the US)

Benefits

• Salary of USD $105k - $120k (depending on experience)
• Equity
• Flexible schedule (we are family-friendly and place importance on finding ways to recharge)
• Training, as required