Advanced Regulatory Affairs Specialist

Bio-Techne • Minneapolis, MN

16d • $62,300 - $102,350 • Onsite

About The Position

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.

Requirements

• 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
• 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

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

Benefits

• competitive insurance benefits starting on day one: medical, dental, vision, life, short-term disability, long-term disability, pet, and legal and ID shield.
• 401k plans, an employee stock purchase plan (ESPP), Health Saving Account (HSA), Flexible Spending Account (FSA), and Dependent Care FSA.
• mentorship, promotional opportunities, training and development, tuition reimbursement, internship programs, and more.
• employee resource groups, volunteer paid time off, employee events, and charity drives
• an accrued leave policy with paid holidays, paid time off, and paid parental leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level