Safety Compliance Engineer

Job description preview

From Philips’s original posting

Job Title Safety Compliance Engineer Job Description Job Responsibilities: Label Development & Execution • Develop and maintain product labels, packaging labels, IFUs, regulatory markings, and country-specific labeling artifacts. • Create and update labeling requirements specifications based on regulatory, safety, engineering, and marketing requirements. • Support new product introductions (NPI), product changes, and sustaining engineering activities. • Generate and manage labeling content within applicable systems and workflows. • Coordinate labeling reviews and approvals with cross-functional stakeholder.Regulatory & Compliance • Ensure medical device labeling complies with global regulations, including FDA, EU MDR, ISO 15223-1, IEC 60601 requirements, UDI requirements, and country-specific regulations. • Support regulatory submissions and audits by providing labeling evidence and documentation. • Participate in labeling risk assessments and verification activities.Change Management • Support labeling-related Change Requests (CRs), Engineering Changes, and Product Releases. • Drive labeling deliverables through change control processes while meeting project timelines. •…