Director, Regulatory Affairs

Regulatory Affairs Manager

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.

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-registrations

Responsible for implementing new or revised Regulatory Requirements mandated by local, federal, or international standards and regulations

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 commitments

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

Flexible Medical, Dental, & Vision Coverage

Competitive 401k company match

Bonus Program, Generous PTO and paid holidays

Generous Tuition reimbursement

Hybrid and flexible work arrangements

Professional development, engagement and events

Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices

Company subsidized cafeteria in our Waltham, MA office

Work Location: Hybrid work schedule, onsite in our Waltham, MA office

Targeted Salary Range: $210,000 - $270,000/year.

Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate's experience and may vary based on individual factors such as location, skills, and education.

At Nova Biomedical, we're not just building instruments, we're powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care.

Our integration brings together more than 70 years of scientific excellence with Nova's cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we're setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences.

With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we're building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity.

Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you'll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health.