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Advanced Regulatory Affairs Specialist

Job Details

Austin, TX - Austin, TX
Full Time
Bachelor's Degree
Quality & Regulatory


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. With the recent acquisitions of Asuragen and ExosomeDx, Bio-Techne has expanded its presence in the molecular diagnostics space. The combination of these businesses into a single Molecular Diagnostics Division provides a set of core capabilities and unique technologies ranging from biomarker discovery to international regulatory expertise and the ability to launch innovative products as both kitted products for international distribution as well as centralized laboratory developed tests.  This division unifies the processes of offering these capabilities and those of the broader Bio-Techne family of brands to pharma partners for projects ranging from biomarker discovery and assay development to full companion diagnostic development and commercialization. 

Position Summary:

The Advanced Specialist, Regulatory Affairs will work closely with internal colleagues and external partners to bring innovative products to market and to support our global commercialization goals. You’ll be a key member of the Regulatory Affairs team working to bring Asuragen products to new markets worldwide.


Key Responsibilities:

  • Represent the Regulatory function at project core team meetings, providing input on project planning, design, development, software, and related technical issues to ensure regulatory requirements for intended markets are met.
  • Contribute to the preparation, filing, and management of regulatory submissions for U.S. and International market clearance or approval of new in vitro diagnostic devices, including the new IVDR and UKCA regulations.
  • Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to international regulatory requirements.
  • Manage processes involved with maintaining annual licenses; registrations; listings and patient information.
  • Ensure compliance with product post-marketing approval and pharmacovigilance requirements.
  • Mentor, guide, and train employees and cross functional team members to increase regulatory affairs awareness.
  • Seek development opportunities to strengthen your subject matter expertise.



Education and Experience:

  • Minimum of 3 years’ experience in an IVD manufacturing environment.
  • Bachelor’s degree (BA/BS) in biology or life science, or equivalent experience.

One or more of the following attributes:

  • Knowledge and experience with molecular in vitro diagnostic (IVD) assays and devices.
  • Knowledge of current and evolving regulations relevant to the approval of IVDs.

Knowledge, Skills and Abilities:

  • Excellent written and oral communication skills.
  • Demonstrated success working on a cross-functional team.
  • Results-driven with demonstrated ability to find solutions to achieve company goals in an effective, efficient manner.
  • Able to flourish in a fast-paced, multi-tasking an dynamic environment
  • Able to build strong relationships across a wide spectrum of internal and external parties.


Why Join Bio-Techne:

We have an incredibly talented group of down-to-earth professionals with the experience, drive and creativity that makes Bio-Techne a world-class global diagnostics company. Our workplace is full of enthusiastic, hardworking and intelligent people with bold ideas and the determination to see them through. 

Our best-in-class reagents, instrument, custom manufacturing, and diagnostic tests are used throughout a patient’s lifespan by laboratories worldwide. Bio-Techne has locations in Minneapolis, MN, Austin, TX, Boston, MA, Denver, CO and San Jose, CA and all sites offer top-notch technology, educational, and business benefits.  Science is our passion; it drives us to collaborate, develop and manufacture award-winning tools that help researchers achieve reproducible and consistent results. 

Bio-Techne provides a competitive salary, medical, dental, disability and life insurance, a 401(k) plan with company matching, an employee bonus plan, and a tuition reimbursement plan.We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. 

Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position

Bio-Techne is an E-Verify Employer in the United States.