Regulatory Affairs Manager

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:

The Regulatory Affairs Manager is responsible for developing and executing global regulatory strategies supporting in vitro diagnostic (IVD) test systems, and other product portfolios throughout the product lifecycle, with primary emphasis on leading pre-market product development, market authorization submissions, and ongoing regulatory maintenance activities. This position serves as a regulatory leader and business partner to Research & Development, Quality, Clinical Affairs, Marketing, Manufacturing, and Senior Functional Leadership to ensure products are developed, registered, and maintained in compliance with applicable global regulations.

The Regulatory Affairs Manager oversees and leads regulatory submissions and registrations within the EU and US and oversees the international registration strategy. The Regulatory Affairs Manager also provides strategic guidance for new product development initiatives in accordance with global regulatory body requirements and manages regulatory personnel. The role monitors evolving global regulatory requirements and industry standards and translates regulatory expectations into practical business solutions that support product commercialization and growth objectives.

Responsibilities:

Regulatory Strategy & Product Development

• Develop and implement global regulatory strategies to support new product development, product modifications, market expansion initiatives, and lifecycle management activities.
• Provide regulatory leadership for pre-market product portfolios, including regulatory pathway assessments and submission planning.
• Partner with cross-functional teams to ensure regulatory requirements are incorporated into product design, development, verification, validation, risk management, labeling, and commercialization activities.
• Provide regulatory leadership for post-market product portfolios, including regulatory change assessments and product change management.
• Assess the impact of changing global regulations and standards on existing and future products.

Regulatory Submissions & Registrations

• Lead preparation, review, submission, and maintenance of global regulatory filings and documentation, including:
• FDA 510(k) submissions.
• US product registrations and listings.
• International product registrations and renewals.
• EU Technical Documentation and Technical Files.
• As required, country-specific regulatory submissions and approvals for regions outside the US and EU.
• Coordinate and lead responses to questions from regulatory agencies and notified bodies.
• Interface directly with FDA, Notified Bodies, Competent Authorities, and other regulatory bodies regarding product approvals and other regulatory matters.
• Maintain facility registrations, product listings, certificates, licenses, regulatory notification requirements, and regulatory approvals for products and product families within scope.

Global Regulatory Compliance

• Ensure ongoing compliance with applicable regulations and standards, including:
• FDA Quality System Regulation (QSR/QMSR).
• MDSAP requirements.
• ISO 13485.
• ISO 14971.
• EU IVDR and related international regulations.
• Provide regulatory guidance during design change assessments and product lifecycle activities, including regulatory impact assessments.
• Oversee labeling, claims review, and promotional material review to ensure regulatory compliance within assigned scope.

Leadership & Team Management

• Manage, mentor, and develop junior Regulatory Affairs personnel as applicable.
• Drive implementation of departmental goals, objectives, and development plans.
• Support establishment of departmental goals, objectives, performance metrics, and development plans.
• Foster a culture of collaboration, accountability, continuous improvement, and regulatory excellence.
• Allocate resources and prioritize activities to meet business and regulatory objectives.

Audits, Inspections & Quality System Support

• Support external audits and inspections conducted by FDA, notified bodies, certification organizations, customers, and business partners.
• Participate in internal audits and quality system improvement initiatives.
• Serve as a regulatory representative on cross-functional review boards and quality committees.
• Provide regulatory input for Management Reviews and Quality System activities.

Experience Requirements:

• Strong knowledge of global medical device and IVD regulations and standards.
• Demonstrated expertise in FDA regulatory submissions, including 510(k) preparation and review.
• Strong understanding of global regulatory frameworks, including EU IVDR, MDSAP, ISO 13485, and ISO 14971.
• Experience developing regulatory strategies for new product introductions and product lifecycle management.
• Ability to interpret regulations, guidance documents, standards, and regulatory expectations and apply them to business objectives.
• Excellent project management, organizational, and prioritization skills.
• Strong analytical, problem-solving, decision-making, risk management, and conflict resolution capabilities.
• Excellent written, verbal, presentation, and interpersonal communication skills.
• Proven leadership, coaching, mentoring, and team development skills.
• Ability to manage multiple projects simultaneously in a fast-paced global environment.
• Experience interacting with global regulatory bodies, including the US FDA, EU Notified Bodies, Competent Authorities.
• Bachelor's degree in Biology, Chemistry, Engineering, Biomedical Engineering, or a related scientific discipline required.
• Advanced degree in Regulatory Affairs, Biology, Chemistry, Engineering, Biomedical Engineering, Public Health, Business Administration, or related field preferred.
• Minimum of 4 years of Regulatory Affairs experience within the medical device, IVD, diagnostics, biotechnology, or healthcare industry.
• Minimum of 3 years of people leadership, supervisory, or management experience.
• Experience working directly with FDA, notified bodies, and international regulatory authorities required.
• Experience leading Class II (US FDA) and/or Class B or C (EU) medical device submissions required. Demonstrated experience preparing and managing US FDA 510(k) or other pre-market submissions highly desired

Physical Requirements and Working Conditions:

• Ability to perform work in an office environment for extended periods.
• Frequent use of computer, keyboard, and telephone equipment.
• Ability to sit, stand, and walk throughout the workday.
• Ability to participate in regulatory audits, inspections, meetings, and presentations.

Why Work for Nova Biomedical

• 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 in Waltham, MA

Targeted Salary Range: $145,000 to $185,000.00

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.

About the Company

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.

Explore what’s next with us at novabiomedical.com

EEO Statement:

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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