Minneapolis, Minnesota, United States · On-site
$62k–$102k/yr
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 researc…
Skills: Regulatory affairs, FDA regulations, EU IVDR, Technical documentation, Risk management
New York, New York, United States · Remote OK
$77k–$126k/yr
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 researc…
Skills: Troubleshooting, Root cause analysis, Customer service, Technical documentation, Hardware support
Minneapolis, Minnesota, United States · On-site
$16/hr–$23/hr
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 researc…
Skills: Laboratory Procedures, Safety Procedures, Basic Math, Reading Comprehension, Problem Solving
Vale of White Horse, England, United Kingdom · Remote OK
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 researc…
Skills: Commercial strategy, Sales leadership, Marketing strategy, Revenue growth, Market share objectives
San Jose, California, United States · On-site
$40k–$66k/yr
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 researc…
Skills: Technical support, Customer service, Troubleshooting, Salesforce, Microsoft Word
United Kingdom · Remote OK
$45k–$71k/yr
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 researc…
Skills: Spatial biology, Immunohistochemistry, Immunofluorescence, In-situ hybridization, Multiomics
Vale of White Horse, England, United Kingdom · On-site
$34k–$55k/yr
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 researc…
Skills: Quality Assurance, ISO 9001, ISO 14001, Internal Auditing, CAPA
Washington, District of Columbia, United States · Remote OK
$83k–$137k/yr
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 researc…
Skills: Scientific sales, Spatial biology, Genomics, Transcriptomics, Account management
Spain · Remote OK
$49k–$79k/yr
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 researc…
Skills: Capital Equipment Sales, Immunoassay Systems, Negotiation, Organizational Skills, Problem Solving
Milan, Lombardy, Italy · Remote OK
$35k–$55k/yr
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 researc…
Skills: Sales Management, Account Management, CRM, SFDC, Market Analysis
Bristol, England, United Kingdom · On-site
$22k–$35k/yr
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 researc…
Skills: Quality Control, Sample Testing, Laboratory Calibration, COSHH Regulations, NMR Analysis
Bristol, England, United Kingdom · On-site
$45k–$71k/yr
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 researc…
Skills: Facilities Management, Engineering Management, GMP Compliance, EHS Management, People Management
San Jose, California, United States · Hybrid
$80k–$131k/yr
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 researc…
Skills: Employee Relations, Talent Management, Leadership Development, Performance Management, Succession Planning
New York, New York, United States · Remote OK
$86k–$141k/yr
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 researc…
Skills: Immunoassay Analysis, Protein Analysis, Assay Development, Technical Support, Data Interpretation
San Jose, California, United States · On-site
$80k–$131k/yr
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 researc…
Skills: Inventory Management, Warehouse Operations, Team Leadership, Shipping and Receiving, Material Handling
Minneapolis, Minnesota, United States · Hybrid
$70/hr–$90/hr
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 researc…
Skills: BGP, Palo Alto Networks, Aruba Switching, Aruba Wireless, Network Segmentation
Indianapolis, Indiana, United States · Remote OK
$83k–$137k/yr
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 researc…
Skills: Consultative Selling, Account Management, Sales Forecasting, Salesforce.com, Territory Management
Osaka, Japan · On-site
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 researc…
Skills: Field Service Engineering, Product Installation, Technical Troubleshooting, Customer Training, SalesForce
Minneapolis, Minnesota, United States · On-site
$40k–$66k/yr
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 researc…
Skills: Pipetting, Electrophoresis, Isoelectric Focusing, Western Blotting, Data Analysis
Minneapolis, Minnesota, United States · On-site
$101k–$166k/yr
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 researc…
Skills: Sales Training, Onboarding, Curriculum Design, E-learning Development, Sales Methodology
Minneapolis, Minnesota, United States • On-site
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The specialist manages regulatory activities for assigned product lines, including leading regulatory filings and maintaining technical documentation. They also provide regulatory guidance during product development and interface with regulatory authorities and notified bodies.
Candidates must have a bachelor's degree in life sciences or a related field with 3–6 years of regulatory experience, or a master's degree with up to 3 years of experience. Strong knowledge of FDA regulations, EU IVDR, and risk management standards is required.
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.
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
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
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
This position requires work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States (e.g., H1-B visa, F-1 visa (OPT), TN visa or any other non-immigrant work status). 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 hr@bio-techne.com for assistance.
Accelerating Spatial Biology.
Lunaphore Technologies S.A., a Bio-Techne brand, is a Swiss-based life sciences company founded in 2014 with the vision of enabling spatial biology in every laboratory. Lunaphore has developed a game-changing chip technology which can extract spatial proteomic and genomic data from tumors and transform any simple assay into multiplex spatial biology without complexity. Lunaphore empowers researchers to push the boundaries of research to ultimately develop the next generation personalized therapies. Community guidelines available here: https://link.lunaphore.com/guidelines
Offices: Route de Lully 5c, Tolochenaz, Vaud 1131, CH
Accelerating Spatial Biology.
Lunaphore Technologies S.A., a Bio-Techne brand, is a Swiss-based life sciences company founded in 2014 with the vision of enabling spatial biology in every laboratory. Lunaphore has developed a game-changing chip technology which can extract spatial proteomic and genomic data from tumors and transform any simple assay into multiplex spatial biology without complexity. Lunaphore empowers researchers to push the boundaries of research to ultimately develop the next generation personalized therapies. Community guidelines available here: https://link.lunaphore.com/guidelines
Offices: Route de Lully 5c, Tolochenaz, Vaud 1131, CH
