Regulatory Affairs Manager

Nova Biomedical • Waltham, MA

1d • $145,000 - $185,000 • Hybrid

About The Position

The Regulatory Affairs Manager develops and executes global regulatory strategies for in vitro diagnostic (IVD) test systems and other product portfolios throughout the product lifecycle. The role primarily leads pre-market product development, market authorization submissions, and ongoing regulatory maintenance. It serves as a regulatory leader and business partner to Research & Development, Quality, Clinical Affairs, Marketing, Manufacturing, and senior functional leadership, ensuring products are developed, registered, and maintained in compliance with applicable global regulations.

The manager leads regulatory submissions and registrations in the EU and US and oversees international registration strategy. The role provides strategic guidance for new product development, monitors evolving global regulatory requirements and industry standards, and translates regulatory expectations into practical business solutions that support commercialization and growth. It also manages regulatory personnel and supports regulatory compliance, audits, inspections, and quality-system activities.

The position is hybrid in Waltham, Massachusetts. The targeted base salary range is $145,000 to $185,000. Nova Biomedical describes itself as a global organization with nearly 2,000 employees.

Requirements

• Bachelor's degree in Biology, Chemistry, Engineering, Biomedical Engineering, or a related scientific discipline.
• Minimum of 4 years of Regulatory Affairs experience in 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.
• Experience leading Class II (US FDA) and/or Class B or C (EU) medical device submissions.
• 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.

Nice To Haves

• Advanced degree in Regulatory Affairs, Biology, Chemistry, Engineering, Biomedical Engineering, Public Health, Business Administration, or a related field.
• Demonstrated experience preparing and managing US FDA 510(k) or other pre-market submissions is highly desired.

Responsibilities

• Develop and implement global regulatory strategies for new product development, product modifications, market expansion, and lifecycle management.
• Lead regulatory pathway assessments and submission planning for pre-market product portfolios.
• Partner with cross-functional teams to incorporate regulatory requirements into product design, development, verification, validation, risk management, labeling, and commercialization.
• Provide regulatory leadership for post-market products, including regulatory change assessments and product change management.
• Assess the impact of changing global regulations and standards on current and future products.
• Lead the preparation, review, submission, and maintenance of global regulatory filings, including FDA 510(k) submissions, US product registrations and listings, international registrations and renewals, EU Technical Documentation and Technical Files, and country-specific submissions as needed.
• Coordinate responses to regulatory agencies and notified bodies and interface directly with FDA, Notified Bodies, Competent Authorities, and other regulatory bodies.
• Maintain facility registrations, product listings, certificates, licenses, regulatory notifications, and product approvals.
• Ensure ongoing compliance with applicable regulations and standards, including FDA QSR/QMSR, MDSAP, ISO 13485, ISO 14971, EU IVDR, and related international regulations.
• Provide regulatory guidance for design change assessments and lifecycle activities, including regulatory impact assessments.
• Oversee labeling, claims, and promotional material review for regulatory compliance within the assigned scope.
• Manage, mentor, and develop junior Regulatory Affairs personnel as applicable.
• Drive implementation of departmental goals, objectives, and development plans; support performance metrics and departmental planning.
• Foster collaboration, accountability, continuous improvement, and regulatory excellence; allocate resources and prioritize work to meet business and regulatory objectives.
• Support external audits and inspections by FDA, notified bodies, certification organizations, customers, and business partners.
• Participate in internal audits and quality-system improvement initiatives.
• Serve as the regulatory representative on cross-functional review boards and quality committees, and provide regulatory input for Management Reviews and quality-system activities.

Benefits

• Flexible medical, dental, and vision coverage
• Competitive 401(k) company match
• Bonus program
• Generous paid time off and paid holidays
• Tuition reimbursement
• Hybrid and flexible work arrangements
• Professional development, engagement, and events
• Company marketplace for lunch and snacks at the Norwood, Billerica, and Westbrook offices
• Company-subsidized cafeteria at the Waltham office

What This Job Offers

• Job Type: Full-time
• Career Level: Manager