Chief Quality / Regulatory Affairs Officer

ABOUT US:

Please make an application promptly if you are a good match for this role due to high levels of interest.

At Vitrafy Life Sciences, we're not just part of the biotech industry, we're redefining it by improving the quality of healthcare treatments by providing effective cryopreservation solutions. Our breakthrough cryopreservation technologies could create new global standards in the way biological materials are preserved, transported, and delivered, ultimately helping preserve life.

Our innovative cryopreservation technology provides cryopreservation solution spanning cryopreservation devices, packaging and an integrated software platform, LifeChain™, focused on retaining the quality of biological material across the entire cryopreservation supply chain.

We are Australian based, with our head office in South Melbourne, manufacturing and scientific lab based in Ballarat and established operations in the US.

ABOUT THE ROLE:

The Chief Quality / Regulatory Affairs Officer for the United States will lead Vitrafy's global quality, regulatory affairs and compliance strategy as the company scales its integrated cryopreservation platform across priority US and international markets. The role will ensure Vitrafy's hardware, smart packaging, software-enabled systems, manufacturing processes, and commercial deployment pathways meet applicable quality, safety, performance, and regulatory requirements throughout the entire product lifecycle, from design and development through regulatory approval, commercialization, and post-market activities.

As the senior US-based quality and regulatory executive, the role will work closely with the Company's executive leadership, product, manufacturing, scientific, commercial and operational teams to embed quality, traceability, evidence generation and audit readiness into Vitrafy's operating model, product lifecycle and market expansion plans.

The role will lead the development of standardized evidence packages, validation documentation and submission templates that allow blood collection centers and other biologics partners to incorporate Vitrafy technology into their own BLA submissions, BLA supplements or comparable filings.

Quality and Regulatory Strategy

• Establish and lead Vitrafy's global quality and regulatory affairs strategy, with an initial focus on US market entry and FDA-facing readiness.
• Define regulatory pathways, evidence requirements and submission strategies for hardware, software, consumables and integrated cryopreservation workflows.
• Provide executive governance across product risk, design controls, validation, change control, labelling, claims, compliance and lifecycle quality.
• Strengthen Vitrafy's credibility with regulators, certification bodies, auditors, strategic customers, partners, investors and the Board.

Quality Management System

• Build and continuously improve a practical, scalable and audit-ready Quality Management System aligned to applicable FDA expectations, ISO 13485 and relevant life sciences standards.
• Oversee audit readiness, internal and external audits, supplier audits, certification audits and regulatory inspections.
• Ensure disciplined document control, CAPA, complaint handling, training records, management review and closure of findings.
• Regulatory Affairs and Market Access
• Lead regulatory planning for Vitrafy's hardware, software, consumables, workflows and related applications, including classification, intended use, evidence requirements, submissions, approvals and lifecycle changes.
• Determine appropriate FDA pathway options, including 510(k), De Novo and PMA pathways where applicable, and align regulatory sequencing with product and commercialization plans.
• Develop regulatory strategies and submission frameworks that enable customers and partners to incorporate Vitrafy technology into their own regulatory submissions, including BLAs, BLA supplements, IND applications and comparable global pathways.

Partner Regulatory Enablement

• Develop reusable regulatory templates, evidence packages and technical documentation for customer and partner regulatory submissions.
• Establish and maintain a standardized BLA Support Package, including validation data, risk assessments, software documentation, process descriptions and clinical or performance evidence where appropriate.
• Support partners in applying Vitrafy documentation to BLA supplements, process changes, comparability protocols and other relevant regulatory filings.

Government, Regulatory and Funding Engagement

• Build and lead Vitrafy's government and regulatory relations program, including engagement with FDA, other regulators, policymakers, legislators, trade associations and industry bodies.
• Develop policy influence, advocacy and funding strategies that support Vitrafy's regulatory, commercial and product development objectives.
• Identify and manage relationships with relevant civilian and military funding bodies and government programs, including BARDA, NIH and the Department of Defense.

Product, Manufacturing and Supplier Quality

• Embed quality and regulatory requirements into design controls, risk management, verification, validation, software lifecycle management, labelling, claims and customer-facing materials.
• Establish quality expectations for internal and external manufacturing, assembly, packaging, labelling, storage, distribution, installation, service and support.
• Oversee supplier qualification, supplier quality agreements, incoming inspection, outsourced process controls and supplier performance monitoring.

Executive Leadership

• Advise the CEO, Board and executive team on quality, regulatory, compliance and product risk matters.
• Establish dashboards and reporting for regulatory milestones, audit readiness, QMS maturity, CAPA, complaints, supplier quality and compliance risks.
• Build, mentor and lead Vitrafy's quality and regulatory affairs capability, including internal roles, external advisors, consultants, systems and operating cadence.

ABOUT YOU:

Required Experience and Qualifications

• Bachelor's degree in life sciences, biomedical science, biotechnology, engineering, pharmacy, quality, regulatory affairs or a related discipline.
• Significant senior leadership experience in quality assurance, regulatory affairs, compliance or product governance within life sciences, biotechnology, medical technology, pharmaceuticals, diagnostics, biologics, cell and gene therapy, laboratory services, animal health or adjacent regulated technology markets.
• Demonstrated experience establishing, scaling or improving quality management systems, ideally including ISO 13485 or equivalent regulated quality frameworks.
• Proven ability to develop regulatory pathways for complex products, platforms or technology-enabled solutions.
• Experience supporting biologics regulatory submissions or developing documentation for blood products, plasma-derived therapies, cell therapies or combination products.
• Strong understanding of FDA CBER expectations and Biologics License Application requirements.
• Experience across design controls, risk management, verification, validation, software lifecycle, manufacturing readiness, post-market surveillance and technical documentation.
• Credibility engaging with regulators, certification bodies, auditors, customers, contract manufacturers, technical partners, executive teams and boards.

Highly Regarded Experience

• Postgraduate qualifications in regulatory affairs, quality management, science, engineering, business or a related field.
• Experience developing regulatory evidence packages, technical documentation or submission frameworks that enable customers or partners to incorporate new technologies into their own submissions.
• Exposure to cryopreservation, biobanking, cold chain, blood products, reproductive technologies, aquaculture, animal genetics, cell and gene therapy, FDA-facing environments, TGA, EU MDR/IVDR, GMP-adjacent operations, cloud-enabled platforms or connected devices.
• Experience supporting products or platforms from development, validation or pilot stage into commercial deployment in a high-growth or internationally expanding business.

Leadership Capabilities

• Regulatory judgement: Converts complex regulatory requirements into practical market access and product lifecycle strategies.
• Quality discipline: Builds systems, controls and documentation habits that support innovation, audit readiness and customer confidence.
• Commercial pragmatism: Balances compliance obligations with speed, scalability, customer outcomes and capital efficiency.
• Cross-border leadership: Operates effectively across US market expectations, Australian-listed governance and international expansion priorities.
• Policy and advocacy: Builds credible relationships with regulators, policymakers, trade associations and funding bodies.

Target Pay Range: $300,000 - $375,000; Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

We anticipate this requisition will be open for a minimum of five days, from August 14, 2026. We encourage your prompt application.

The Perks!: Our benefits include medical, dental, and vision plan options. We also support long-term financial well-being through a 401(k) plan, along with unlimited vacation and sick time programs to help employees maintain a healthy balance between work and life. xhyhwjd

Ready to Preserve the Future with Us?

If you're ready to join a fast-growing biotech leader where your work drives global change, Vitrafy Life Sciences is your next move.