Visby Medical

Compliance

• Navigate the complex FDA landscape to bring innovative molecular IVD products to market
• Coordinate, prepare, and manage complex regulatory submissions (FDA 510(k), De Novo, presubmissions)
• Proactively identify and mitigate risks to regulatory timelines and plans
• Draft and review clinical/non-clinical protocols and reports to ensure data integrity and compliance
• Collaborate with cross functional teams to provide regulatory guidance throughout the product lifecycle process
• Lead the end-to-end product labeling process, including drafting technical text and managing design controls
• Own and manage the company's unique device identification (UDI) program
• Review/approve promotional and advertising and labeling materials to ensure regulatory compliance and alignment
• Partner on Human Factors activities, including defining usability requirements and conducting risk analyses

Regulatory Affairs Specialist

Director

• Maintain a robust and effective QMS that is compliant with relevant regulations (e.g., FDA QSR, ISO 13485) and consensus standards.
• Serve as the company’s management representative by reporting to top management on the effectiveness of the QMS and the need for any improvements.
• Ensuring promotion and awareness of the QMS and of applicable regulatory requirements.
• Actively participate in the day-to-day QMS activities and develop an in-depth knowledge of the drivers of product quality.
• Stay abreast of changes to relevant quality system regulations and consensus standards and ensure that Visby’s QMS is appropriately updated.
• Collaborate with supply chain and subject matter experts to ensure the quality and reliability of suppliers and contractor manufacturers though the use of supplier controls.
• Ensure that effective supplier quality agreements are developed and implemented with suppliers and contractor manufacturers, including those located outside the United States.
• Ensure that risk management activities are effectively used to drive improvement to product quality throughout the product life cycle.
• Oversee software quality assurance, including software verification activities and collaborating with stakeholders to ensure implementation of cybersecurity requirements.
• Oversee an efficient and effective document control system.
• Ensure that quality audits are planned, conducted and that effective corrective actions are taken when needed.
• Serve as the company point of contact with external quality system auditors (e.g., FDA).
• Ensure effective quality system training and establish metrics to monitor training effectiveness.
• Ensure efficient and effective quality control processes and procedures, including use of appropriate sampling techniques.
• Foster a culture of quality throughout the organization by promoting awareness, accountability and continuous improvement.

Director of Quality

Financial Planning and Analysis

• Actively participate in the development of strategic corporate goals while empowering the executive team and board to make risk-informed, data-driven decisions.
• Serve as the lead spokesperson for financial results and strategic milestones.
• Build and maintain deep relationships with equity analysts, venture/PE partners, and institutional investors.
• Serve as the primary interface to the audit committee of the Board of Directors; present financial and operational plans to the Board.
• Provide confidence and assurance to the Board regarding the Company’s operations through transparency, integrity, and professionalism.
• Support the growth of the business through comprehensive due diligence and skilled financial analysis of potential acquisitions and other strategic investment opportunities.
• Improve the quality, timeliness, and reliability of financial analysis and key performance metrics available to executive management and the Board, including forecasting, budgeting, and resource allocation in all functional areas.
• Ensure compliance, clean audits, proper reporting and controls.
• Motivate and lead a high-performance team of financial and accounting professionals.

Fractional Chief Financial Officer

Chief Marketing Officer

• Partner with the CEO and executive team to define Visby’s go-to-market roadmap for the OTC and retail segments
• Position Visby as the most trusted name in molecular self-testing
• Translate market, consumer, and competitive insights into actionable strategies
• Define pricing, packaging, and channel strategies in collaboration with Product, Commercial, and Regulatory teams
• Lead all aspects of brand identity, creative, and messaging across digital, retail, earned, and owned channels
• Oversee integrated campaigns that connect science and lifestyle
• Lead product marketing across the OTC portfolio
• Partner with R&D and Medical Affairs to translate complex technology into clear, compelling consumer benefits
• Build and scale an omnichannel growth engine spanning digital acquisition, retail partnerships, and e-commerce
• Build, mentor, and lead a multidisciplinary marketing organization across brand, creative, growth, and insights

People Operations

• Provide executive support to the CEO, including complex calendar management, meeting coordination, and correspondence.
• Prepare and organize executive communications, presentations, and internal updates.
• Attend meetings as needed, capture key decisions and action items, and help drive follow-through.
• Conduct research and synthesize information to support informed decision-making.
• Manage travel logistics, offsites, conferences, and company events.
• Handle sensitive and confidential matters with the highest level of discretion.
• Act as a trusted and approachable resource for employee questions including general HR inquiries.
• Manage onboarding and offboarding processes, ensuring a welcoming employee experience.
• Maintain electronic employee files.
• Assist in developing and maintaining employee handbooks, policies, and HR process documentation aligned with company values and best practices.
• Maintain data integrity within HRIS systems.
• Support and administer benefit programs, employee leaves, workers compensation, etc.
• Support recruiting logistics, follow-ups, and referral communications while contributing to a high-quality candidate experience reflective of Visby’s culture and standards.

Regulatory Affairs Specialist

Director of Quality

Fractional Chief Financial Officer

Chief Marketing Officer

Executive Business Partner