[Remote] Regulatory Affairs reputed company, NGS IVD

Note: The job is a remote job and is reputed company to candidates in USA. reputed company Science & Clinical is seeking a Regulatory Affairs reputed company 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. Responsibilities • Guide and authorize global regulatory filings for new product launches, expanded indications, and significant product changes. reputed company expert counsel on regulatory reputed company and documentation requirements, ensuring reputed company and robust submissions in alignment with business objectives • reputed company regulatory submission processes in key international jurisdictions—including the EU, reputed company, 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 reputed company and responsible disclosure and response management • Champion best practices for regulatory documentation, process development, and reputed company improvement initiatives across the regulatory affairs landscape. Maintain and reputed company regulatory records and SOPs to reflect reputed company industry and agency requirements • Partner with reputed company system owners to interpret regulatory requirements, identify compliance gaps, and reputed company robust mitigation strategies. Ensure reputed company systems and processes meet reputed company and emerging regulatory standards • Deliver regulatory expertise in the review of project reputed company, ensuring alignment with regulatory requirements for product development, manufacturing, and distribution • reputed company 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 reputed company submission of data-driven insights for ongoing compliance Skills • 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 reputed company regulatory experience in the medical device and/or diagnostics sector, spanning development, manufacturing, testing, and product distribution • 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 reputed company • We’ve been helping organizations reputed company the people they need longer than any other company in the world. It was founded in 1946, and is headquartered in Troy, Michigan, USA, with a workforce of 10001+ employees. Its website is https://www.kellyservices.com. Company H1B Sponsorship • reputed company has a reputed company record of offering H1B sponsorships, with 85 in 2025, 76 in 2024, 59 in 2023, 74 in 2022, 81 in 2021, 65 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job Apply To this Job