DIALITY INC

Role Description The Regulatory Affairs Director is responsible for overseeing, developing, and influencing regulatory policy and determining and pursuing courses of action necessary to obtain regulatory clearance and approval for the Diality products. This position is also responsible for supporting the Quality Management System and will serve as the Regulatory Affairs lead on product teams. The Regulatory Affairs Director will also act as the Regulatory Responsible Person as defined by the EU MDR. - Develops regulatory strategic plans and provides support to ensure adherence with global regulatory requirements. - Plans and prepares regulatory submissions for new products and product changes, including: - US FDA Investigational Device Exemption (IDE) - US FDA 510(k) - CE Marking under EU MDR - Product amendments to existing regulatory approvals/clearances - Serves as the primary contact with US Food and Drug Administration (FDA) and liaises with other country Regulatory Agencies. - Represents Diality in cross-industry regulatory initiatives. - Responsible for obtaining and maintaining: - Local, State and National Regulatory licensing and registration renewals - Import/Export Permits - Assesses product and manufacturing changes and develops regulatory assessments for each market. - Provides assistance and regulatory guidance regarding product labeling, marketing materials, and social media. - Provides oversight for Regulatory processes and systems. - Supports Quality System projects and activities, including: - Complaint Handling - Post-market vigilance and clinical follow-up activities. - Leads inspections/audits by the notified body or other international regulatory Agencies. - Participates in and reviews risk management activities/documents to ensure compliance with ISO 14971. - Maintains a “big picture” perspective, taking personal responsibility for actions and maintaining a commitment to regulatory compliance, quality, ethics, and integrity. Qualifications - Demonstrated excellence in developing global regulatory affairs strategies for medical products. - Broad-based technical knowledge and skills in diverse areas of business such as Engineering, Operations, Quality, Marketing, Clinical Research, etc. - Ability to effectively negotiate and influence cross-functional stakeholders, affiliates, and Regulatory authorities. - Proven track record of maintaining regulatory knowledge and skills by participating in industry conferences/seminars. - Comprehensive knowledge of laws and regulations applicable in an FDA-regulated environment. - Strong working knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR regulations. - Good knowledge of clinical evaluation and investigation of medical devices. - Excellent interpersonal skills including ability to interact with a high degree of diplomacy. - Excellent problem-solving, applied thinking, and technical writing skills. - Excellent communication and organization skills required. - Ability to work in a fast-paced, technically challenging environment. - Expertise in Microsoft Office and Adobe Acrobat applications. - Familiarity with dialysis and end-stage renal disease is a plus. Requirements - Minimum science or engineering BS degree with at least 10+ years of medical device regulatory affairs experience or a Regulatory Affairs MS or PhD with at least 7+ years of medical device regulatory affairs experience. - Certification in regulatory affairs (RAC) preferred. - 2+ years of Regulatory Affairs leadership in a small/start-up company environment. - Previous experience interacting directly with FDA is required. - Experience reviewing and approving technical documentation. - US and EU medical device regulatory submission experience required. - Hands-on experience with 510(k) and Technical File/Design Dossier submissions. - Product development team experience. Travel - Ability to travel (domestic and international) as required, approximately 10%. Physical Requirements - Prolonged periods of sitting at a desk and working on a computer. - May be expected to lift 15 pounds at times. Working Environment - Office or work-station environment. - Remote work environment is also an option for this position.

Role Description Diality is seeking a highly skilled and experienced FP&A Analyst. Responsibilities are to lead our financial planning and analysis (FP&A), budgeting and forecasting functions. The FP&A Analyst will play a critical role in driving financial performance by delivering insights, forecasts, and analyses that support executive decision-making. This role requires strong analytical skills, business acumen, and the ability to communicate financial concepts clearly to both financial and non-financial stakeholders. - Assist in the development of annual budgets, quarterly reforecasts, and long-range financial models. - Partner with department leaders to align forecasts with business initiatives and key performance indicators (KPIs). - Prepare monthly and quarterly management reports, highlighting variances against budget/forecast and providing actionable insights. - Conduct detailed financial modeling and scenario analysis to support various business initiatives, cases, capital investments, and strategic initiatives. - Monitor KPIs and provide commentary on trends, risks, and opportunities. - Support automation and process improvements, and development of financial systems and reporting tools. - Collaborate with cross-functional teams (Engineering, Operations, Sales, HR, etc.) to ensure alignment of financial assumptions with business strategies. - Provide financial insights that inform leadership decisions regarding growth, efficiency, and profitability. - Serve as the primary owner of the company’s long-range financial model, ensuring it evolves as the business scales. - Collaborate with leadership to integrate financial assumptions into product launch readiness and manufacturing scale-up planning. Qualifications - Strong analytical, quantitative, and problem-solving skills. - Advanced proficiency in Excel (financial modeling, scenario analysis, pivot tables, macros). - Excellent communication skills with the ability to translate complex financial concepts into business insights. - Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment. Requirements - Bachelor’s degree in Accounting or Finance required. - 10-15 years of progressive FP&A or strategic finance work experience. - Strong experience with budget ownership and variance analysis, including scenario modeling and financial assessments. - Experience supporting process automation or system improvements. Travel - Travel to headquarters (Irvine, Ca) as necessary. Physical Requirements - Sustained periods of time sitting in a sedentary light office position with high frequency typing and computer use. - Sitting at a desk utilizing a computer. - Primarily remote work on a remote team.