Regulatory Affairs Specialist II, Animal Health

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

Austin TX. Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States withoutsponsorship.

*Must be able to pass a comprehensive background check which includes a drug screen.

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 as well as for post-market surveillance and compliance activities.

A day in the Life

• Write coordinate compile and submit regulatory documents to agencies with a focus on the USDA for the Animal Health product portfolio.

• Engage regulators through oral and written communications to discuss submissions and requirements and to 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 training and provide materials to enhance the teams 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

• Bachelors degree in life sciences bioengineering or related science required.

Experience

• 2 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 required.

• Experience working with USDA regulations required.

• 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!