Job Title: SCR Compliance Engineer
Location: Bothell , WA -Hybrid- 3 days in office 2 days home
Duration: 12 months+
Pay: $60.97/hr on w2

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

Key Responsibilities

Product Compliance & Regulatory Strategy

• 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

Standards & Requirements Management

• 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:
  • Standards & Compliance Plans (SCPs)
  • Compliance assessments
  • Market-access evaluations
• Drive implementation of new regulatory requirements into development processes

Product Safety & Certification

• 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.

Labeling, Packaging & Environmental Compliance

• Review product labeling, packaging, user documentation, and marketing claims for compliance.
• Ensure compliance with applicable requirements such as:
  • Electrical Safety
  • EMC
  • Chemical compliance (RoHS, REACH, POPs, Prop 65, etc.)
  • Battery regulations
  • Packaging regulations (including EU PPWR)
  • Environmental sustainability requirements
  • Country-specific labeling requirements
• Approve regulatory aspects of engineering change orders and product releases.

Risk Management & Issue Resolution

• 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.

Audits & Quality System Support

• 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.

Cross-Functional Collaboration

• Partner with:
  • Regulatory Affairs
  • R&D
  • Systems Engineering
  • 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.

Required Qualifications

Education

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

Experience

• 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.(Suggested consolidation based on responsibilities found in the sourced descriptions.)

Technical Knowledge

Knowledge of one or more of:

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

Preferred Qualifications

• Experience with client products.
• Knowledge of Oral Healthcare products including power toothbrushes and oral irrigators.
• Experience with:
  • SCP development
  • RMM management
  • Market access assessments
  • Sustainability regulations
  • Global packaging and labeling regulations
  • Regulatory intelligence programs

Success Measures

A successful SCR Compliance Engineer:

• Enables compliant product launches on schedule.
• Identifies regulatory risks early and drives mitigation plans.
• Maintains up-to-date compliance documentation.
• Supports successful audits and certifications.
• Ensures products remain compliant throughout their lifecycle.
• Serves as a trusted compliance advisor to project teams and business leaders.