Kelly · 8 hours ago
Regulatory Affairs Principal, NGS IVD
United States
Contract
Remote
Lead/Staff
$55/hr - $80/hr
8+ years expKelly Science & Clinical is seeking a Regulatory Affairs Principal for a 6-month contract-to-hire position with a leading biotechnology company. The role involves ensuring compliance of molecular diagnostic products with global regulatory frameworks and driving cross-functional engagement across teams for strategic submissions and regulatory compliance.
OutsourcingProfessional Services
Hiring Manager
Alexandre Neves, Ph.D.
Responsibilities
Guide and authorize global regulatory filings for new product launches, expanded indications, and significant product changes. Provide expert counsel on regulatory strategy and documentation requirements, ensuring timely and robust submissions in alignment with business objectives
Direct regulatory submission processes in key international jurisdictions—including the EU, APAC, and Australia—while taking primary accountability for compliance under IVDR and other region-specific frameworks
Design and execute global change notification strategies for modifications to registered products. Safeguard regulatory adherence and ensure seamless implementation in alignment with U.S. and international standards
Represent the organization in communications with regulatory authorities, notably in the context of notifiable nonconformances, adverse events, and post-market issues. Ensure prompt and responsible disclosure and response management
Champion best practices for regulatory documentation, process development, and continuous improvement initiatives across the regulatory affairs landscape. Maintain and evolve regulatory records and SOPs to reflect current industry and agency requirements
Partner with quality system owners to interpret regulatory requirements, identify compliance gaps, and develop robust mitigation strategies. Ensure all systems and processes meet current and emerging regulatory standards
Deliver regulatory expertise in the review of project contracts, ensuring alignment with regulatory requirements for product development, manufacturing, and distribution
Keep cross-functional teams informed of new or evolving regulatory standards, expanded claims, recalls, and adverse event updates. Support annual post-launch monitoring and reporting, ensuring timely submission of data-driven insights for ongoing compliance
Qualification
Required
Bachelor's degree with 12+ years, Master's degree with 8+ years, or PhD with 5+ years of relevant regulatory experience
Minimum of 6 years of direct regulatory experience in the medical device and/or diagnostics sector, spanning development, manufacturing, testing, and product distribution
Preferred
Advanced degree (Master's or PhD) strongly preferred
Proven leadership in managing regulatory submissions with the FDA, EMA, and other major ex-US regulatory bodies
Demonstrated expertise in both U.S. and international IVD regulatory frameworks
Comprehensive understanding of post-market surveillance regulations, best practices, and reporting procedures
Company
Kelly
We’ve been helping organizations find the people they need longer than any other company in the world.
10001+ employees
H1B Sponsorship
Kelly has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (85)
2024 (76)
2023 (59)
2022 (74)
2021 (81)
2020 (65)
Funding
Current Stage
Public CompanyTotal Funding
unknown1978-01-13IPO
Leadership Team
Chris Layden
Chief Executive Officer
N
Nicholas Zuhlke
Vice President, Controller, and Chief Accounting Officer
Recent News
Kelly Services, Inc.
2025-11-08
2025-11-08
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