The Manager, Technical RegulatoryCompliance,is responsible forleading compliance activities related to technical and regulatory requirements across the organization. This role ensures that technical processes, documentation, and system implementations align with applicable regulatory standards, quality system requirements, and internal policies. The position plays a critical role in managing compliance risk, supporting audit andinspection ofreadiness, and enabling compliant execution of technical initiatives by partnering closely with Quality, Regulatory Affairs, Engineering, and IT teams.

Key Responsibilities

• Lead and manage technical regulatory compliance activities, ensuring adherence to regulatory and quality system requirements.

• Provide compliance oversight for technical processes, systems, and documentation supporting regulated activities.

• Interpret regulatory and technical standards and translate them into actionable compliance requirements.

• Partner with Quality, Regulatory Affairs, Engineering, and IT teams to support compliantsystemsand process implementation.

• Support internal audits, external audits, and health authority inspections related to technical compliance.

• Monitor compliance risks, trends, and performancemetrics;drivecorrectiveand preventive actions.

• Ensure consistent application of global and regional compliance policies, procedures, and controls.

• Drive continuous improvement initiatives to strengthen technicalcompliance,governance,and effectiveness.

Qualifications

Education:

• Bachelor’s degree in Regulatory Affairs, Quality, Engineering, Life Sciences, Information Systems, orrelateddiscipline (required).

• Advanced degree in a scientific, regulatory, or technical field (preferred).

Experience and Skills:

Required:

• Typically,6-8 years of progressive experience in Regulatory Compliance, Quality Systems, Engineering, or related roles within a regulated industry.

• Strong working knowledge of regulatory and technical requirementsimpactingquality systems and processes.

• Experience supporting audits, inspections, and compliance assessments.

• Ability to manage complex technical compliance topics across cross‑functional stakeholder groups.

Preferred:

• Experience in medical devices, healthcare, or other highly regulated industries.

• Familiarity with EMEA regulatory and technical compliance frameworks.

• Experience working in a global or matrixed organization.

• Exposure to regulatory inspections involving technical or system compliance.

• Quality or Regulatory certifications (e.g., RAC, ASQ).

• Strong analytical, risk‑management, and problem‑solving skills.

• Effective written and verbal communication skills.

Other:

• Language: Englishrequired;additionalEuropean languages preferred.

• Travel: Moderate regional travel across EMEA.

• Certifications: Quality or Regulatory certifications preferred but notrequired