Biotechne
Advanced Regulatory Affairs Specialist
Minneapolis, MN · Internship
Sponsorship not specified$62k-$102kDetected 30 days ago
Product ManagementProject ManagementNegotiationFDA RegulatoryMedical DevicesResearchExperimental DesignLeadershipCommunicationRegulatory Affairs
About the role
- 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.
- This role operates with limited supervision and is responsible for ensuring compliant and efficient execution of regulatory deliverables across the product lifecycle.
Responsibilities
- Lead preparation and submission of regulatory filings:
- Own regulatory impact assessments for:
- Design changes (IVDR Article 110(3), significant change evaluations)
- Develop and maintain core technical documentation e.g.:
- Study design input (analytical/clinical performance)
- Lead cross-functional regulatory reviews (design reviews, risk reviews, labeling reviews)
- Support OEM and private label regulatory strategies, including contract manufacturing considerations
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
- Ability to interpret complex regulatory requirements and prepare recommendations and executive summaries to management
Skills
- Highly self-motivated, with support as needed
- Bio-Techne, and all of its brands, provides tools for researchers to further treat and prevent disease worldwide.
Compensation
- $62,300.00 - $102,350.00 The Advanced Regulatory Affairs Specialist independently manages regulatory activities for assigned product lines and contributes to regulatory strategy.
Benefits
- 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.
- Education and Experience:
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