Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeAs part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
This position is located in Austin, Texas, and is part of the Regulatory Affairs group. This position functions within 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.
Discover Impactful Work
Join us to help build the future of science and healthcare by ensuring regulatory compliance in our innovative Animal Health product lines. The Regulatory Affairs Specialist III will be responsible for defining and implementing regulatory strategy, providing regulatory guidance and support to product development teams for planning, design and development, and post-market surveillance and compliance activities.
A day in the Life
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 current on Animal Health regulations, guidance documents, notices, and competitor news.
Coordinate regulatory issue resolution using internal resources, agencies, and outside 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 projects.
Keys to Success
Education
Minimum requirement of a Bachelor’s degree in life sciences, bio-engineering or related science.
Experience
A minimum of 2-4 years of proven experience in Animal Health Diagnostic (preferred) or Human IVD Regulatory Affairs. This experience may include a combination of Animal Health VDx as well 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.
Knowledge, Skills, Abilities
Experience in regulatory affairs, including strategy 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 impact
Effective in matrixed environments and conflict resolution.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
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