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19 days old

Sr Regulatory Affairs Specialist

Kelly Services
Irvine, CA 92604
Kelly Services Outsourcing & Consulting Group is hiring a Sr. Regulatory Affairs Specialist in Irvine CA to work for a top sponsor client. This is a full time long term position with benefits! The Sr. Regulatory Affairs Specialist will develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable medical device regulations and standards.





RESPONSIBILITIES:



Ensure compliance with global regulations and regulating agencies.



Interpret the intent of regulations and policies and provide such information to project teams and management.



Develop Technical Documentation Files following the requirements of the EU Medical Device Regulation for class II and III medical devices to obtain or maintain CE Marking.



Conduct submission negotiations with the European Notified Bodies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.



Maintain proficiency on regulatory requirements and develop and maintain rapport with Notified Body reviewers, project team members.



Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.



Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured



Follow all Company guidelines related to Health, Safety and Environmental practices.



Comply with all Federal, State, local and Company regulations, policies, and procedures.



Performs other duties assigned as needed.





QUALIFICATIONS:



Bachelors Degree in engineering, physical or biological science or related field of study; MS degree preferred.



6+ years experience in the clinical medical device industry with at least five (5) years in Regulatory Affairs of Medical Devices.



Regulatory experience with devices containing software preferred.



Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, EU Medical Device Regulation, FDA Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations.



International clinical and regulatory experience desired.



Prefer experience in the cardiovascular/cardiology field.



Must be able to communicate effectively in a professional environment.



Must be able to influence without authority





LOCATION & TRAVEL REQUIREMENTS



Location: Irvine, CA, with possibility to work remotely per arrangements with manager.



Travel: 10% travel, both domestic and international





If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!





This position comes with enhanced benefits which include:



50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*



Paid sick days and vacation days*





Perks of being a Kelly employee:



Weekly electronic pay



Access to more than 3,000 online training courses though Kelly Learning center



Online application system



Never an applicant fee





*benefits to be received upon meeting eligibility requirements





Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.






**Why Kelly** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-12-30 Expires: 2020-02-06

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Sr Regulatory Affairs Specialist

Kelly Services
Irvine, CA 92604

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