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.

POSITION SUMMARY

Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations, and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance, and standards. Assist in creation and maintenance of regulatory files.

Perform additional duties as assigned.

ESSENTIAL FUNCTIONS

Works in the regulatory affairs department on assigned projects.

Maintain regulatory files.

Coordinates with product development and/or research and development teams to request, develop, and prepare required data and reports to be submitted to regulatory bodies and agencies.

Collaborates with key staff from Planning, Product Development, Operations, and Legal departments as required.

Review and approve documents, labels, and other documentation.

Assist with design control activities.

Assist in Risk Management activities.

Follows company policies and practices as outlined in the Handbook and follows guidelines regarding safety as outlined in the AWAIR, Chemical Hygiene and Exposure Control manuals in accordance with the job.

Perform additional duties as assigned.

Education and Experience: 

An Associate degree with 3-5 years of relevant experience;

Or, a Bachelor's degree with up to 3 years of relevant experience

Knowledge, Skills, and Abilities:  

Attention to detail and organizational skills are required

Working knowledge of Microsoft Word and Excel are required

Computer entry, typing, or electronic document filing skills are required.

Must be able to work in a fast-faced environment where multitasking is required 

Must have excellent verbal and written communication skills 

Knowledge of technical, regulatory, quality and production management systems

Knowledge of documentation principles and processes

Skills in accuracy, clarity and proofreading

Skills in problem solving, identifying root cause and appropriately evaluate a course of actions

Why Join Bio-Techne:

We offer competitive wages along with extensive benefits for employees and their families.We invest in our employees’ financial futures through retirement programs and an employee stock purchase plan.We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, and more.We offer an international and diverse working environment, enriched by employee resource groups; volunteer and charity events; and employee events that build a culture of caring and belonging. We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.

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

Bio-Techne is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

To protect the interests of all, Bio-Techne will not accept unsolicited resumes from any source other than a candidate application. Any unsolicited resumes sent to Bio-Techne will be considered Bio-Techne property.

Pay Range:

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