Regulatory, Safety & Compliance Director

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our team to enable our customers to make the world healthier cleaner and safer.

DESCRIPTION

Division: Materials & Structural Analysis Division (MSD)

Location Site Based: Brno Czech Republic open to consider candidates from Poland Austria & Slovakia who are open to relocate for the role.

The Regulatory Safety & Compliance Director leads the division-level Regulatory Affairs (RA) Product Safety and Compliance program for Electron Microscopy and EFA instruments. This role ensures that all products meet applicable global regulatory requirements across markets where MSD operates supporting safe product development commercialization and lifecycle management. The position plays a critical role in enabling compliant innovation driving regulatory excellence and ensuring alignment with Thermo Fisher Scientifics quality and compliance standards.

Key Responsibilities:

• Lead the MSD-wide Product Safety & Compliance program ensuring adherence to global regulatory requirements for instruments and consumables.
• Ensure all applicable regulations are identified and maintained for each market where MSD products are placed on the market or put into service.
• Ensure compliance with Product Safety EMC Environmental Chemical and Dangerous Goods regulations and provide supporting evidence to the Sr. Director Quality & Regulatory as input for stage-gate reviews within the Product Management Process (PMP).
• Define and implement meaningful Key Performance Indicators (KPIs) to measure the effectiveness efficiency and compliance of Product Safety and Compliance processes.
• Serve as a subject matter expert in global regulatory frameworks including CE NRTL FCC WEEE RoHS REACH and SCIP.
• Lead the Product Quality Advisory Committee (PQAC) for field incidents ensuring structured problem solving through CAPA and RCCM methodologies.
• Support internal and external audits third-party inspections and manage coordination with accredited test laboratories.
• Ensure Safety Data Sheets (SDS) are developed and maintained to support global product shipments.
• Drive Regulatory Intelligence by monitoring emerging regulations interpreting their impact on MSD products and proactively establishing compliance programs.
• Establish and maintain systems and processes to ensure all new product developments meet regulatory and safety requirements from concept through commercialization.
• Recruit hire coach and mentor a high-performing team to meet organizational and business needs.
• Represent Regulatory Safety & Compliance within the Product Lifecycle Council (PLC) to ensure integration across the product lifecycle.
• Act as a PPI (Practical Process Improvement) Process Manager driving continuous improvement and standardization of compliance processes.
• Participate in industry organizations and standards bodies to remain current on evolving regulations and best practices.

REQUIREMENTS

Minimum Qualifications:

• Masters degree in Engineering Life Sciences Regulatory Affairs or a related field (advanced degree preferred).
• Significant experience in regulatory affairs product safety or compliance within a global manufacturing medical device or life sciences environment.
• Strong knowledge of international regulatory requirements and standards (CE FCC RoHS REACH etc.).
• Demonstrated leadership experience managing teams and cross-functional programs.

Preferred Qualifications:

• Experience with electron microscopy analytical instrumentation or complex capital equipment.
• Deep understanding of product lifecycle processes (PMP/PLC) and stage-gate governance.
• Experience with quality systems CAPA processes and field incident management.
• Certification or experience in continuous improvement methodologies (PPI Lean Six Sigma).
• Active participation in regulatory or industry standardization organizations.

Key Competencies:

• Strategic and regulatory leadership
• Global regulatory expertise and risk management
• Cross-functional collaboration and influence
• Data-driven decision making (KPIs and metrics)
• Continuous improvement mindset (PPI)
• Strong communication and stakeholder engagement