Advanced Regulatory Affairs Specialist

By joining Bio-Techne, you’ll join a company with a powerful and positive purpose of enabling cutting-edge research in Life Sciences and Clinical Diagnostics. Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.

Pay Range:

$62,300.00 - $102,350.00

 

Position Summary: 

The Advanced Regulatory Affairs Specialist provides independent support to senior regulatory staff to submit regulatory filings and support regulatory activities. This position will demonstrate advanced knowledge of regulatory changes and assist with communication to customers and regulatory authorities. In this position, you will work closely with internal colleagues and external partners to bring innovative products to market and support our business goals. 

 

Key Responsibilities: 

• Ensure compliance with global regulatory requirements, monitor industry changes, and provide strategic input on regulatory initiatives. 

• Manage, prepare, and submit regulatory filings, licenses, and registrations while maintaining compliance with QMS and post-market surveillance requirements. 

• Facilitate regulatory meetings, guide teams, and support internal and external stakeholders, including global regulatory authorities. 

• Identify process enhancements, mentor internal partners, and propose regulatory best practices. 

• Assess product history, advise on global regulatory strategy, review change controls, and support labeling, promotional, and advertising materials. 

• Develop and execute global regulatory strategies, ensuring compliance with FDA and international medical device regulations. Monitor industry trends, analyze regulatory changes, and provide strategic recommendations to maintain compliance. 

 

Education and Experience: 

• Bachelor's degree in related field with 3-5 years of relevant experience in regulatory affairs in an IVD manufacturing environment; Or, a master’s degree with up to 2 years of relevant experience 

 

Knowledge, Skills, and Abilities: 

• Strong attention to detail, organizational skills, and ability to manage workload independently. 

• Applied knowledge of FDA and international medical device regulations, global regulatory strategy, and submission processes. 

• Introductory knowledge of molecular genetics and commonly used technologies (e.g., PCR, Capillary Electrophoresis, Genetic Analyzers) is a plus. 

• Proficiency in Microsoft Word, Excel and electronic document management. 

• Excellent verbal and written communication skills with the ability to build strong relationships across internal and external teams including regulatory agencies. 

• Ability to adapt to dynamic environment, prioritize effectively, and drive results with a solution-oriented mindset.  

Preferred Experience/Skills 

• Previous experience authoring 510(k)s  

• Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements. 

• Regulatory experience in the IVD medical device industry  

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