Regulatory Affairs Consultant

Adecco USA

Adecco is currently assisting a local client in their search to fill a Regulatory Affairs Consultant position located in San Diego, CA! This is a long term opportunity for the right person. If you would like to pursue a great opportunity and enjoy working for a fast paced company, then Apply Now if you meet the qualifications listed below! 

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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

Adecco provides one of the most comprehensive benefits packages in the industry to contract employees.

Candidates interested in this Opportunity should apply IMMEDIATELY. DO NOT DELAY. Please click on the “Apply Now” button to fill out your application. If you have any questions, you can contact Kristin Kaiser at [email protected]
This position is being recruited for by Adecco’s Service Delivery Center, not your local Adecco Branch Office. To be considered for this position, you must use the “apply now” button to submit your resume. If you have questions about the position, you may contact the recruiter recruiting for this position listed above, however your resume must be received via the “apply now” button included within to be considered.

The Adecco Group is a global leader in HR services.  Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world.  We offer employment opportunities at any stage in your professional career.  Contact us today to discuss available contract and direct hire positions.  Adecco Group offers benefits including Holiday, 401(k), Insurance Benefit Plans and Service/Anniversary Bonus opportunities.  

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