Senior Manager, Regulatory Compliance

Preferrednice to have

• Master's degree in Engineering, Regulatory Affairs, Quality, Business, or related discipline.
• RAC, ASQ CQE, or equivalent professional certification.
• Experience in biotechnology, life sciences, medical devices, laboratory equipment, or bioprocessing industries.
• Experience with compliance management systems and supplier data management platforms.

Product Compliance

• Oversee programs supporting compliance with global product regulations and standards, including but not limited to: EU RoHS, REACH and SCIP, TSCA, PFAS regulations and reporting requirements, CE Marking, UKCA, WEEE, Packaging and Packaging Waste Regulation (PPWR), Conflict Minerals and Responsible Minerals Reporting, Country-specific product compliance requirements.

• Provide strategic guidance on compliance requirements throughout the product lifecycle.
• Ensure regulatory compliance requirements are integrated into product development, design control, and change management processes.
• Lead regulatory risk assessments and support mitigation planning for identified compliance gaps.

• Oversee customer compliance support processes, including responses to regulatory inquiries and requests for compliance documentation.
• Direct supplier compliance data collection and assessment activities.
• Establish frameworks and processes for managing supplier declarations, material disclosures, and regulatory documentation.
• Support key customer audits and regulatory assessments as required.

• Lead, coach, and develop Regulatory Compliance team members.
• Establish performance objectives and development plans aligned with departmental and organizational goals.
• Build accountability and foster a high-performance culture focused on collaboration, service excellence, and continuous improvement.
• Support workforce planning, resource allocation, and succession planning activities.
• Mentor regulatory professionals and enhance organizational regulatory competency.

• Partner with Quality, Engineering, R&D, Product Management, Operations, Procurement, and Commercial teams to ensure regulatory requirements are effectively implemented.
• Influence decision-making across functions to support business objectives while maintaining compliance.
• Present compliance status, risks, and strategic recommendations to senior management.
• Lead cross-functional efforts to resolve complex compliance issues and regulatory challenges.

• Drive implementation and optimization of regulatory compliance tools, databases, and digital solutions.
• Establish and monitor regulatory compliance metrics and key performance indicators.
• Ensure appropriate documentation, records management, and audit readiness.
• Support internal audits, external audits, customer audits, and regulatory inspections.
• Manage departmental budgets and external service providers associated with compliance programs.

Leadership Responsibilities

• Provides direct leadership and supervision to regulatory compliance professionals.
• Translates strategic objectives into operational plans and measurable outcomes.
• Leads multiple regulatory programs and initiatives across global business functions.
• Makes operational decisions influencing departmental performance and long-term compliance objectives.
• Builds strong relationships with internal stakeholders, external consultants, customers, suppliers, and regulatory authorities.

• Paid time off

• Health, dental and vision insurance

• Retirement benefits

• Flexible spending accounts

• Variable cash bonus or commission

• Equity eligibility