Alveo Technologies - Alameda, CA

posted 2 days ago

Full-time - Senior
Alameda, CA
Computer and Electronic Product Manufacturing

About the position

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.

Responsibilities

  • 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
  • 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
  • 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
  • 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
  • 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

Requirements

  • 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
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