Regulatory Analyst I

Key Responsibilities

• Serve as the designated regulatory representative for product registrations, listings, licenses, notifications, and approvals, ensuring accurate and timely submission to regulatory authorities.
• Prepare, coordinate, and compile European Union Technical Documentation, Canadian and other International Regulatory packages and supporting documentation to meet regional and global requirements.
• Act as the primary regulatory point of contact for internal and external stakeholders, providing guidance on regional registration requirements and communicating the regulatory impact of product changes. Ensure timely communication with stakeholders to meet regulatory requirements.
• Cross-Functional Coordination: Coordinate regulatory activities and communications to support submission timelines, project milestones, and alignment with stakeholders.
• Create, review, update, and maintain regulatory documentation and records within approved document management systems in accordance with document control requirements, ensuring records remain accurate, current, and readily accessible for audits, inspections, and submissions.
• Support continued commercialization by ensuring regulatory approvals and registrations are maintained in compliance with applicable regulations and quality system requirements.

Required Regulatory Knowledge

• In Vitro Diagnostic Regulation (IVDR): Broad working knowledge of EU IVDR (Regulation (EU) 2017/746) requirements, including classification, conformity assessment, technical documentation, and registration obligations for in vitro diagnostic devices.
• Canadian Regulations: Broad knowledge of Health Canada regulatory requirements, including the Medical Devices Regulations (SOR/98-282), medical device licensing (MDL), establishment licensing (MDEL), and applicable registration and listing requirements.
• Global Regulatory Frameworks: Familiarity with applicable international regulatory requirements to support multi-region registration, licensing, and ongoing compliance activities.

Documentation & Records Control

• Maintain regulatory records and documentation—including submission files, registrations, licenses, approvals, and supporting records—ensuring version control, timely revision to reflect product or registration changes, and retention in compliance with applicable document control procedures.
• Ability to maintain confidentiality of information and materials.

Custom Fields

• Name: OpCo Value: Beckman Coulter DX
• Name: Is an interview required? Value: Yes
• Name: Manager Requested Bill Rate Value: 35.89
• Name: Special Equipment Required? Value: None

Why Work With Us?

We believe in more than just jobs—we build careers. At Net2Source, we champion leadership at all levels, celebrate diverse perspectives, and empower you to make an impact. Think work-life balance, professional growth, and a collaborative culture where your ideas matter.

Our Commitment to Inclusion & Equity

We are an equal opportunity employer, dedicated to fostering a workplace where diverse talents and perspectives are valued. We make all employment decisions based on merit, ensuring a culture of respect, fairness, and opportunity for all, regardless of age, gender, ethnicity, disability, or other protected characteristics.

Awards & Recognition

• America’s Most Honored Businesses (Top 10%)
• Fastest-Growing Staffing Firm by Staffing Industry Analysts
• INC 5000 List for Eight Consecutive Years
• Top 100 by Dallas Business Journal
• Spirit of Alliance Award by Agile1

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