Safety Compliance Manager

SCR Compliance Engineer (Safety, Compliance & Regulatory Engineer) Job Summary

The Compliance Engineer is responsible for ensuring that Oral Healthcare products comply with applicable global regulatory, safety, environmental, chemical, packaging, labeling, and market‑access requirements throughout the product lifecycle. The role serves as the primary compliance representative within cross‑functional product development teams and is responsible for identifying compliance risks, implementing regulatory requirements, supporting certification activities, and ensuring products can be legally marketed in intended countries.

• Represent the Safety, Compliance & Regulatory (SCR) function within product development teams.
• Translate regulatory and standards requirements into product requirements and design inputs.
• Ensure compliance with applicable international, regional, and country‑specific regulations and standards.
• Evaluate regulatory implications of design changes, material changes, labeling changes, packaging changes, and software updates.
• Identify and communicate regulatory and compliance risks throughout development and sustaining activities.

• Maintain awareness of evolving regulations, standards, and industry guidance.
• Assess impact of new or revised standards on existing and developing products.
• Support creation and maintenance of compliance assessments and market‑access evaluations; drive implementation of new regulatory requirements into development processes.

• Coordinate safety and compliance testing activities.
• Review and approve test plans and test reports.
• Support certification activities with external laboratories, certification bodies, and approval agencies.
• Maintain technical files and compliance evidence supporting regulatory submissions and certifications.
• Serve as primary contact for country approval and approbation activities where required.
• Review product labeling, packaging, user documentation, and marketing claims for compliance.
• Ensure compliance with applicable requirements such as:
  • Electrical Safety
  • EMC
  • Battery regulations
  • Packaging regulations (including EU PPWR)
  • Environmental sustainability requirements
  • Country‑specific labeling requirements
• Approve regulatory aspects of engineering change orders and product releases.
• Investigate safety and compliance issues.
• Perform root cause analysis using structured methodologies (e.g., 8D).
• Support corrective and preventive actions.
• Assess potential impact of field issues, customer complaints, standards changes, and regulatory findings.

• Support internal audits, external audits, regulatory inspections, and certification reviews.
• Ensure compliance activities are performed in accordance with Quality Management System requirements.
• Support maintenance of compliance records and technical documentation.
• Support departmental metrics and continuous improvement initiatives.

Partner with:

• Regulatory Affairs
• R&D
• Quality
• Manufacturing
• Procurement
• Marketing
• Supply Chain
• Sustainability teams
• Provide regulatory and compliance guidance to project teams and leadership.
• Support project gate reviews and product release decisions.

• Bachelor's degree in Engineering, Regulatory Affairs, Quality Engineering, Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related scientific discipline.

• 3–7+ years of experience in product compliance, regulatory affairs, quality, safety engineering, certification, or related fields.
• Experience working within regulated product environments.
• Experience supporting product development projects from concept through commercialization.

Knowledge of one or more of:

• IEC/EN/UL standards
• Electrical Safety
• EMC
• Product Labeling
• Chemical Compliance
• Market Access Requirements
• Quality Management Systems
• Regulatory Submission Processes
• Certification and Approval Processes

• Experience with Philips Personal Health products.
• Knowledge of Oral Healthcare products including power toothbrushes and oral…