Bio-Techne
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
3–6+ 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:
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 hr@bio-techne.com for assistance.