Regulatory Affairs Principal, IVD

Kelly Science, Engineering, Technology & Telecom; California (MO); Remote; Full time

Job summary

A leading molecular diagnostics company is seeking a Regulatory Affairs Principal for an 18-month contract. This remote role involves leading New Product Development teams, managing regulatory submissions, and ensuring compliance for product launches in US and EU markets.

Qualifications

• 8+ years experience with Bachelor's, 6+ with Master's, 3+ with Doctorate.

Responsibilities

• Manage regulatory submissions for US and EU IVDR and WHO PQ.
• Communicate with regulatory agencies for approvals.
• Develop strategies for product launches in US, EU, and WHO markets.

Skills

Regulatory Submissions

Project Leadership

Regulatory Strategy

Continuous Improvement

Education

Bachelor's degree

Master's degree

Doctorate

Job description

Kelly Science, Engineering, Technology & Telecom provided pay range

This range is provided by Kelly Science, Engineering, Technology & Telecom. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/yr - $63.00/yr

Position Overview

Kelly Science & Clinical is recruiting a Regulatory Affairs Principal for an 18-month contract with a leading molecular diagnostics company in Sunnyvale, CA. This role involves translating scientific discoveries into advancements and advancing your career in biotech.

Workplace and Position Details

Workplace: Remote (USA)

Position Title: Regulatory Affairs Principal, New Product Development

Pay rate: $60-63/hour

Role Summary

The Regulatory Affairs Principal leads on New Product Development (NPD) teams, working on assay, instrument, software, and system projects. Responsibilities include preparing regulatory submissions, ensuring on-time product launches, and collaborating across functions to introduce new products and foster career growth within Regulatory Affairs.

Key Responsibilities

• Regulatory Submissions: Manage submissions for US and EU IVDR and WHO PQ, ensuring compliance and timely launch.
• Agency Interaction: Communicate with regulatory agencies and authorities to address queries and obtain approvals.
• Regulation Interpretation: Interpret new regulations affecting US and EU markets.
• Continuous Improvement: Use DBS tools to improve processes within regulatory domain.
• Reporting: Prepare reports and presentations on strategies and project status.
• Qualifications: Bachelor's degree with 8+ years, Master's with 6+ years, Doctorate with 3+ years of relevant experience.
• Project Leadership: Lead NPD core teams for complex projects.
• Regulatory Strategy: Develop strategies for product launches in US, EU, and WHO markets.
• Documentation: Prepare regulatory submissions including FDA pre-submissions, 510(k), and PMA.

Preferred Qualifications

• CLIA waiver experience is a plus.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Consulting, Quality Assurance, and Science
• Industries: Research Services, Biotechnology Research, Medical Equipment Manufacturing

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