What are the responsibilities and job description for the Director, Regulatory Affairs (Animal Health) position at CorDx?
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
Salary range is $120,000 - $170,000 per year
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%
PTO
Medical insurance
Paid Holiday
401K
We are an equal opportunity employer and value diversity at CorDx. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Salary : $120,000 - $170,000
