GLOBAL REGULATORY PROFESSIONAL/ENGINEER-MED DEVICE

Location: SUNNYVALE, CA
Date Posted: 11-04-2018
We are pleased to present the following job opportunity with our client!  Take a look and if you meet the requirements please submit your resume and we'll be in touch if you're a good fit!

Key Responsibilities: 
* Provide world-wide regulatory consulting, strategy, and plans for LSAG products and ensure alignment of regulatory compliance with development and manufacturing teams 
* Clarify global regulatory requirements and provide guidance on implementation  
* Support the development and execution of global regulatory strategy for LSAG medical device products in collaboration with Enterprise RAQA, LSAG senior management, and other appropriate groups 
* Assist with key processes such as risk management, design control, labeling control, change management, complaint handling, CAPA, and recall/field action 
* Evaluate effectiveness of regulatory compliance processes and identify areas for improvement 
* Educate the LSAG organization on key regulatory topics as well as the importance and benefits of achieving compliance 
* Monitor global regulatory changes and work with regulatory managers to ensure LSAG products and processes are compliant 
* Participate in facility inspections and audits from regulatory authorities and certification bodies in collaboration with the Enterprise RAQA function 
* Provide guidance / advice on the development and maintenance of global regulatory files for LSAG products

Required Qualifications: 
* Bachelors in Engineering, Scientific or technical discipline, prefer Masters or University Degree with 15+ years business experience in the IVD/Medical Device industry 
* Expertise in ISO 9001:2015 and Medical Device Regulations such as FDA QSR and EU IVDD as well as related standards (ISO 13485, ISO 14971, IEC-61010-2-101) 
* Technical Knowledge of global product regulations, including RoHS, REACH, WEEE, Safety, EMC, and other similar EU Directives 
* Experience in establishing and managing a global regulatory strategy (including registrations, product listings/submissions) for medical device products 
* Demonstrated industry experience integrating, guiding, and influencing global resources across several complex departments or functions 
* Strong Project Management and leadership abilities as well as excellent communication and problem-solving skills 
* Excellent technical report writing skills  

Preferred Qualifications: 
* Knowledge of Medical Regulations in Asia (China, Korea, Japan, etc.) 
* Experience in Product Development and Commercialization
* Proficient in Improvement Methodologies (6 Sigma, PDCA, RCA) 
* Involvement with LSAG Products (LC/LCMS, GC/GCMS, ICPMS, etc.) 
* Experience in Clinical Affairs as well as in Diagnostic and/or Clinical Testing 
Very competitive salary and benefits!
Great company to work for!
Full relocation package is available!
Don't miss out! Apply now and we'll be in touch immediately with more specific details, salary information and to answer any questions!!

This position does NOT provide sponsorship so please do NOT apply if you require sponsorship.  Thank You

KP Recruiting Group 
"Bringing Talent to the Marketplace"

KP Recruiting Group is a well established and very respected recruiting firm.  We have built a strong reputation as a premier resource for providing highly qualified candidates for our clients.  We are very experienced in many industries and have a wide range of clients.  We will serve as your advocate during your career search!  Let us do the work for you!  There is never a fee for our services!



 
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