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
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.
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 Philips Personal Health 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
How We Work Together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
For this project, you'll be contracted via a Randstad company as a temporary worker/contractor and placed at Philips.
The hourly pay range for this role is $55.00-60.00
As a contractor, you'll enjoy cutting-edge challenges and unexpected experiences that make you a more in-demand professional.
Equal Opportunity Employer
Randstad is an equal opportunities employer and does not discriminate against Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact kari.carapella@randstadsourceright.com
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