Bio-Techne · 8 hours ago
Advanced Regulatory Affairs Specialist
Minneapolis, MN
Full-time
Onsite
Entry, Mid Level
$62K/yr - $102K/yr
2+ years expBio-Techne is a company focused on enabling cutting-edge research in Life Sciences and Clinical Diagnostics. The Advanced Regulatory Affairs Specialist will be responsible for regulatory affairs activities, ensuring compliance with medical device regulations, and collaborating with various teams to prepare regulatory submissions and reports.
BiotechnologyGeneticsManufacturingMedicalMedical Device
Responsibilities
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
Qualification
Required
A Bachelor's degree with 2-4 years of relevant experience
Or, a Master's degree with up to 3 years of relevant experience
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-paced 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 evaluating a course of actions
Knowledge of global regulations associated with in-vitro diagnostics
Technical document writing skills
Benefits
We offer competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
We invest in our employees’ financial futures through 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
We empower our employees develop their careers through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
We offer an accrued leave policy with paid holidays, paid time off, and paid parental leave.
We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Company
Bio-Techne
Bio-Techne is a supplier of tools for life science research, therapeutic manufacturing, and clinical diagnostics.
1001-5000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown1989-05-19IPO
Leadership Team
Kim Kelderman
President and CEO
Gary Latham
Chief Technology Officer
Recent News
2025-12-24
2025-12-13
Company data provided by crunchbase