Chief Quality / Regulatory Affairs Officer

At Vitrafy Life Sciences, we’re redefining the biotech industry by improving the quality of healthcare treatments through effective cryopreservation solutions. Our breakthrough cryopreservation technologies aim to create new global standards in preserving, transporting, and delivering biological materials, ultimately helping preserve life. Our innovative cryopreservation technology includes devices, packaging, and an integrated software platform, LifeChain™, designed to retain the quality of biological material across the entire cryopreservation supply chain. We are based in Australia, with our head office in South Melbourne, manufacturing and scientific lab 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. This role ensures 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, you will collaborate 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 involves leading the development of standardized evidence packages, validation documentation, and submission templates to enable blood collection centers and other biologics partners to incorporate Vitrafy technology into their own BLA submissions, BLA supplements, or comparable filings.

Responsibilities

• 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, labeling, claims, compliance, and lifecycle quality.
• Strengthen Vitrafy’s credibility with regulators, certification bodies, auditors, strategic customers, partners, investors, and the Board.
• 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.
• 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.
• 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.
• 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.
• Embed quality and regulatory requirements into design controls, risk management, verification, validation, software lifecycle management, labeling, claims, and customer-facing materials.
• Establish quality expectations for internal and external manufacturing, assembly, packaging, labeling, storage, distribution, installation, service, and support.
• Oversee supplier qualification, supplier quality agreements, incoming inspection, outsourced process controls, and supplier performance monitoring.
• 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.

Requirements

• 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.

Qualifications

• Postgraduate qualifications in regulatory affairs, quality management, science, engineering, business, or a related field (highly regarded).
• Experience developing regulatory evidence packages, technical documentation, or submission frameworks that enable customers or partners to incorporate new technologies into their own submissions (highly regarded).
• 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 (highly regarded).
• Experience supporting products or platforms from development, validation, or pilot stage into commercial deployment in a high-growth or internationally expanding business (highly regarded).

Skills

• 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.

Pay

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.

Benefits

• Medical, dental, and vision plan options.
• 401(k) plan to support long-term financial well-being.
• Unlimited vacation and sick time programs to help maintain a healthy work-life balance.