Philips Regulatory Affairs Specialist 

South Africa, Free State, Dihlabeng Local Municipality 

15944457

Your role:

• Lead a team within Regulatory or Cross Functional Team to set and deliver the objectives
• Communicate application progress to internal stakeholders
• Collaborate with worldwide colleagues regarding license renewals and updates
• Maintain regulatory files and tracking databases as required
• Communicate with regulatory agencies as needed
• Ensure standard and process compliance.
• Provide audit, CAPA and post market regulatory support
• Mentor other regulatory affairs personnel within HPM Regulatory

You're the right fit if:

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

• Bachelor’s degree required in a technical/engineering discipline.
• Master’s preferred preferably in Regulatory Affairs and/or related field (or equivalent experience in the medical device industry)
• RAPs RAC strongly preferred.
• ASQ certifications also desirable.
• Minimum of 3 years of experience in the medical device industry (EU MDD, Health Canada, US FDA class II or class III, etc.).
• Proficient knowledge of medical device regulations minimum FDA and Canada, Worldwide is desired
• Able to work effectively with minimal supervision
• Proficient knowledge of domestic and international standards
• Strong background in Design Controls.
• Experience in supporting international registrations and/or clinical investigations.
• Experience with Software Medical Devices strongly preferred.
• Proficient computer skills in Microsoft Office Suite
• Understand LEAN concepts, methodologies and deployment.
• May require 5% travel annually with possibly some international.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

• Learn more about .
• Discover
• Learn more about
• Read more about .

If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.