Regulatory Affairs Specialist

Advanced Regulatory Affairs SpecialistBy 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 - $102,350.00The 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 interactionsInternational 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 modificationsDevelop and maintain core technical documentation e.g.:Performance evaluation reportsDevice performance characteristics data reportsProvide regulatory guidance during product development:Study design input (analytical/clinical performance)Intended purpose and claims developmentInterface directly with regulatory authorities and Notified Bodies on routine mattersLead cross-functional regulatory reviews (design reviews, risk reviews, labeling reviews)Support OEM and private label regulatory strategies, including contract manufacturing considerationsMentor junior regulatory staff and review their work for accuracy and complianceEducation and Experience:Bachelor's degree in life sciences or related field3–6+ years of regulatory affairs experience in the biotech industry Or Master's degree with up to 3 years of relevant experienceKnowledge, Skills, and Abilities:Highly self-motivated, with support as neededFoundational knowledge of:IVDR Controls and CalibratorsLaboratory practicesStrong working knowledge of:FDA regulations (21 CFR)Risk ManagementLaboratory calculations and data managementAbility to interpret complex regulatory requirements and prepare recommendations and executive summaries to managementDemonstrated experience preparing regulatory submissionsStrong project management and cross-functional leadership skillsEffective negotiation and communication with internal stakeholders and external regulators/partnersProficient in business software systems and electronic workflows relevant to the roleStrong working knowledge of:EU IVDR (2017/746), FDA regulations (21 CFR 807, 809, 820/QMSR)ISO 13485 and ISO 14971CLIA StandardsWhy 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.