Director, Regulatory Affairs

Nova Biomedical: One Global Brand. One Vision. Together under one name.

Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets.

Job Summary:

• Oversees and leads the Regulatory Affairs function to ensure global regulatory requirements are met for Nova products including but not limited to: U.S. FDA 21 CFR Part 820 (Quality Management System Regulation (QMSR), ISO 13485:2016,; EU Regulation (EU) 2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 2002); Australian Therapeutic Goods (Medical Devices) Regulations 2002 (incl. Schedule 3); Canadian Medical Devices Regulations (SOR/98-282); Brazil GMP requirements (ANVISA RDC 665/2022); and Japan QMS requirements (MHLW Ministerial Ordinance No. 169.
• Serves as Deputy Person Responsible for Regulatory Compliance (PRRC
• Responsible for leadership, development, and management of an effective and compliant Regulatory Affairs team working closely with company cross functional members to ensure processes meet the needs of regulations as well as functional excellence.
• Responsible for Regulatory team leadership driving global new product registrations and clearances as well as mandatory re-registration.
• Responsible for implementing new or revised Regulatory Requirements mandated by local, federal, or international standards and regulations

Responsibilities:

• (Regulatory Affairs ):Develop and maintain global regulatory strategy and determine effective regulatory pathways for a variety of IVD and life science product types across the full product lifecycle.
• Partner with cross-functional leaders (R&D, Clinical/Medical, Quality, Manufacturing/Operations, Marketing, Supply Chain) to integrate regulatory and clinical evidence needs into development plans, design controls, and change control.
• Ensure product development projects and changes to existing products are conducted in compliance with applicable global regulations and standards, and that regulatory deliverables are met to support on-time submissions and launches.
• Leads RA team in the preparation of U.S. and international submissions (e.g., Pre-Sub/meeting requests, 510(k), and EU IVDR Technical Documentation for CE marking) and other related regulatory filings.
• Lead preparation, review, and approval of regulatory submissions and associated technical documentation (U.S., EU IVDR, and other international markets), including responses to deficiency letters and maintenance submissions/variations.
• Serve as primary regulatory contact for FDA, MHRA, Notified Bodies, and other regulatory authorities; lead agency interactions (e.g., Pre-Subs/consultations), and support inspections, audits, and follow-up commitmentss
• Collaborate with R&D and MASA to determine and execute pre- clinical and performance evidence strategy for IVDs, including performance evaluation planning (scientific validity, analytical performance, and clinical performance as applicable) and evidence generation to support intended use/claims and regulatory submissions.
• Own post-market regulatory obligations, including vigilance/adverse event reporting, Field Safety Corrective Actions/recalls (as applicable), regulatory reporting, and support for post-market performance follow-up and performance evaluation report updates under IVDR, as well as post-market surveillance and vigilance requirements under UK MDR 2002.
• Provide regulatory review/approval for labeling, IFUs, promotional materials, and claims to ensure alignment with cleared/approved intended use and regional advertising/labeling requirements.
• Maintain regulatory intelligence program to monitor and implement new or revised regulatory requirements; assess business impact, drive compliance plans, and communicate changes to stakeholders
• Lead, develop, and mentor the Regulatory Affairs organization; establish scalable processes, templates, training, and metrics.