Regulatory Affairs Specialist

Job Title – Regulatory Affairs Consultant
 
Job Location – San Diego CA
 
Length – Contract (12 Months+)
 
Philips Healthcare is looking for a regulatory affairs consultant to work with R&D teams on various programs (e.g. IDE, manufacturing). 
This individual will assist R&D teams in developing regulatory strategy, regulatory plans and protocols, and creating submission documentation. 
 
 Background/skills/capabilities required for this engagement: 
• Experience working in international regulatory affairs 
 • Ability to provide strategic and execution-level regulatory affairs support (e.g. draft regulatory filing documents) 
 • Experience reviewing regulatory affairs elements of Clinical Evaluation Reports (CER), Risk Management files, Verification and Validation Reports, labeling 
 • Experience with disposable devices (e.g. guidewires/catheters/sheath introducers) would be preferred as an understanding of materials, biocompatibility, and sterility would be beneficial 
 
 Key Deliverables – Key Success Factors: 
 • Regulatory strategy guidance for client teams 
 • Development of regulatory plan and protocols 
 • Development of regulatory submission documents 
 • Facilitate implementation of new Regulations such as EU Medical Device Regulations 
 • Participate in NPD as the Regulatory core team member 
 • Review of documents and project deliverables including but not limited to: 
 o Clinical Evaluation Reports (CER) 
 o Risk Management files 
 o Verification and Validation Reports 
 o Labeling
 
Best,
Kushal Shah
APN Software Service INC
kushal@apninc.com

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