Director, Regulatory Affairs (Animal Health)
Alameda, CA
Regulatory, Quality, and Clinical Affairs /
Full Time /
Hybrid
About Alveo
Alveo Technologies is the first company to make molecular detection and diagnostics universally accessible – on the farm, in the field, in the clinic, or in the manufacturing plant – helping prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens by detecting earlier at the Point of Need™. Alveo’s rugged and portable, multiplex-capable diagnostic platform employs IntelliSense™, its patented method of direct electrical sensing of nucleic acid amplification to provide affordable, rapid, and accurate results. By enabling early pathogen detection, Alveo helps manage global health, food security, and supply chain resiliency by providing actionable insights at lightspeed. Know Sooner, Act Faster™ with Alveo. For more, visit: https://www.alveotechnologies.com/
Alveo Technologies is looking for a dynamic highly skilled regulatory affairs professional. You are a clear and articulate communicator and a great listener and observer that can work effectively with other teams across the organization. In this role, you will combine regulatory, scientific and veterinary diagnostic
expertise to develop and execute regulatory strategies to ensure the successful approval and compliance of our products in the global market. Your expertise in USDA CVB regulations and international veterinary diagnostic requirements will be instrumental in shaping our regulatory pathway. You will collaborate cross-functionally to support product development, registration, and post-market compliance while maintaining strong relationships with regulatory authorities.
Key Responsibilities:
Regulatory Strategy Development
Design and execute regulatory strategies to support the development, registration, and commercialization of veterinary diagnostics
Provide regulatory guidance to R&D, Quality Assurance, and Clinical Affairs to ensure compliance with applicable standards and guidelines
Anticipate regulatory challenges and develop risk-mitigation strategies to accelerate approval timelines
Regulatory Submissions and Approvals
Lead the preparation, submission, and lifecycle management of regulatory dossiers to USDA CVB and other global regulatory agencies
Ensure timely submission and approval of product licenses, manufacturing licenses, and supplemental applications
Maintain expertise in VS Memoranda, CVB policies and other applicable guidance impacting veterinary diagnostics
Regulatory Compliance and Policy Monitoring
Monitor global regulatory trends and policy updates, ensuring internal compliance with USDA CVB, APHIS, and international regulatory frameworks
Maintain up to date knowledge of regulatory changes and communicate their impact to the organization
Support regulatory inspections and audits, providing necessary documentation and support, and drive continuous compliance improvements
Cross functional Collaboration
Work closely with R&D, Quality Assurance, Clinical Affairs, and Commercial Marketing teams to integrate regulatory considerations throughout the product lifecycle
Support regulatory training initiatives, ensuring teams remain up to date on compliance requirements
Technical Documentation and Communication
Develop and maintain regulatory policies, SOPs and technical documentation to support regulatory submissions and audits
Provide regulatory content for design history files and maintain compliance documentation
Effectively communicate with regulatory authorities, responding to inquiries, represent the company in meetings and negotiations
Qualifications:
Minimum of a bachelor's degree in life sciences or veterinary medicine
Minimum of 10 years previous experience in regulatory affairs with a focus on veterinary diagnostics
An depth knowledge of regulatory requirements for US, EU, MENA, and other international geographies
Deep expertise in USDA CVB regulatory pathways and guidance documents, including experience with product development, licensure, and post-approval compliance
Problem solving skills and the ability to get to yes or no quickly
Excellent communication and teamwork skills, and the ability to adapt and interface effectively with a wide range of stakeholders
Travel 0 - 10%
Salary range is $196,686 - $205,000 per year
We are an equal opportunity employer and value diversity at Alveo Technologies. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
