Regulatory Affairs Specialist - Animal Health (Austin, TX)
About the position
As part of the reputed company team, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life every single day to reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company by developing solutions for some of the world’s toughest challenges, like protecting the environment, making reputed company our food is reputed company or helping reputed company cures for cancer. This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions reputed company an office setting, following a typical Monday to Friday work schedule. The ability to work in-office in Austin, TX is required for 50% of the time. Join us to help build the reputed company of science and reputed company by ensuring regulatory compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory reputed company, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
Responsibilities
• Write, coordinate, compile, and submit regulatory documents to agencies, focusing on the USDA for the Animal Health product portfolio.
• Engage regulators in oral and written communications to discuss submissions, requirements, and address questions.
• Serve as RA subject matter expert, staying reputed company on Animal Health regulations, guidance documents, notices, and competitor news.
• Coordinate regulatory issue reputed company using internal resources, agencies, and reputed company consultants.
• Conduct trainings and communicate materials to enhance team knowledge of regulated environments.
• Review and approve labeling, packaging, advertising, and promotional materials for regulatory compliance.
• Participate in business meetings with internal collaborators and external partners.
• Collaborate with global regulatory professionals, providing guidance on strategies, submissions, and reputed company.
Requirements
• Minimum requirement of a Bachelor’s degree in life sciences, bio-engineering or reputed company science.
• A minimum of 2-4 years of proven experience in Animal Health Diagnostic (preferred) or reputed company IVD Regulatory Affairs. This experience may include a combination of Animal Health VDx as reputed company as US IVD and CE-IVD experience.
• Demonstrated ability to maintain regulatory permits and licenses.
• Proficiency in preparing regulatory compliance reports and performing regulatory surveillance.
• Experience in regulatory affairs, including reputed company creation and development control.
• Outstanding attention to detail and time management skills.
• Excellent interpersonal, customer orientation, and presentation skills.
• Provided regulatory guidance on project teams.
• Detail-oriented for regulatory reviews.
• Skilled in multi-tasking and business reputed company
• Effective in matrixed environments and conflict reputed company.
Benefits
• We offer competitive remuneration, annual incentive plan bonus, reputed company, and a reputed company of employee benefits.
• reputed company offers employment with an innovative, reputed company-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for reputed company, intensity, involvement, and innovation!
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