Opportunity Description
**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:
$49,700.00 - $81,650.00
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 chang...
Pay Range:
$49,700.00 - $81,650.00
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 chang...
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