Advanced Regulatory Affairs Specialist

Key Responsibilities

• Lead preparation and submission of regulatory filings: FDA (510(k), PMA, Q-Submission, etc.), EU IVDR technical documentation and Notified Body interactions, International registrations (e.g., Canada, Australia, Japan, Brazil)
• Own regulatory impact assessments for: Design changes (IVDR Article 110(3)), significant change evaluations, Labeling updates and claims modifications
• Develop and maintain core technical documentation: Performance evaluation reports, Device performance characteristics data reports
• Provide regulatory guidance during product development: Study design input (analytical/clinical performance), Intended purpose and claims development
• Interface directly with regulatory authorities and Notified Bodies on routine matters
• Lead cross-functional regulatory reviews (design reviews, risk reviews, labeling reviews)
• Support OEM and private label regulatory strategies, including contract manufacturing considerations
• Mentor junior regulatory staff and review their work for accuracy and compliance

Education And Experience

• Bachelor’s degree in life sciences or related field
• 3–6+ years of regulatory affairs experience in the biotech industry
• Or Master’s degree with up to 3 years of relevant experience

Knowledge, Skills, And Abilities

• Highly self-motivated, with support as needed
• Foundational knowledge of: IVDR, Controls and Calibrators, Laboratory practices
• Strong working knowledge of: FDA regulations (21 CFR), Risk Management, Laboratory calculations and data management
• Ability to interpret complex regulatory requirements and prepare recommendations and executive summaries to management
• Demonstrated experience preparing regulatory submissions
• Strong project management and cross-functional leadership skills
• Effective negotiation and communication with internal stakeholders and external regulators/partners
• Proficient in business software systems and electronic workflows relevant to the role
• Strong working knowledge of: EU IVDR (2017/746), FDA regulations (21 CFR 807, 809, 820/QMSR), ISO 13485 and ISO 14971, CLIA Standards

Benefits

• Competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield
• Investment in employees’ financial futures through 401k plans, employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA
• Empowerment of employees’ career development through mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more
• Employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging
• Accrued leave policy with paid holidays, paid time off, and paid parental leave
• Foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table

About the role

Join Bio-Techne, a company dedicated to enabling cutting-edge research in Life Sciences and Clinical Diagnostics. As an Advanced Regulatory Affairs Specialist, you'll manage regulatory activities for assigned product lines and contribute to regulatory strategy.