Advanced Regulatory Affairs Specialist

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

The Advanced Regulatory Affairs Specialist independently manages regulatory activities for assigned product lines and contributes to regulatory strategy. This role operates with limited supervision and is responsible for ensuring compliant and efficient execution of regulatory deliverables across the product lifecycle.

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 e.g.:
• 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
• 36+ 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

Why Join Bio-Techne:

• 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.

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

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.

If you require a reasonable accommodation to complete an application, participate in an interview, or take part in any other stage of the recruitment process, please contact View email address on click.appcast.io for assistance.