Onsite (full-time presence in the company’s facilities required)
International registrations management
Regulatory information validation
Regulatory database maintenance
The Sr Regulatory Operation Specialist position at Philips requires a candidate with extensive experience in medical device regulatory affairs, focusing on international registrations and compliance. The role emphasizes strong analytical skills and expertise in regulatory databases, with a collaborative culture that values teamwork and impact
Job Summary
This role involves managing international registrations, labeling, and regulatory compliance activities for medical devices across multiple regions including the USA, Canada, and EU.
The position requires collaboration with regulatory and cross-functional teams to ensure alignment with company objectives and compliance with relevant regulations.
Philips emphasizes a culture of working better together, encouraging in-person collaboration at least three days per week for office-based teams.
Matching Summary
Match Score: 85
The Sr Regulatory Operation Specialist position at Philips requires a candidate with extensive experience in medical device regulatory affairs, focusing on international registrations and compliance. The role emphasizes strong analytical skills and expertise in regulatory databases, with a collaborative culture that values teamwork and impact.
Skills & Requirements
Must-have
International registrations management
Regulatory information validation
Regulatory database maintenance
Regulatory submissions preparation
Label change request monitoring
Dashboard creation and reporting
Product registration and listing
Nice-to-have
Data analytical skills with Office 365 tools
Collaboration with cross-functional teams
Process improvement initiatives
Regulatory intelligence gathering
Stakeholder communication
Continuous improvement mindset
Independent initiative driving
Key Requirements
Degree in engineering or related discipline
10 years professional experience in medical device regulatory affairs
RAPS RAC certification preferred
Experience with quality management and product development systems
Bachelor's or vocational education in Biomedical Engineering or related fields preferred