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Global Regulatory Affairs Director - Orange County CA- Medical Devices
$150,000 -$200,000 plus benefits
A fantastic career opportunity has just arisen for a Global Regulatory Affairs Director to come and join one of the world's largest Medical Devices organisations. This innovation organisation is looking for a talent to come and join their success and provide strong capability to lead and support a collaborative team environment. This company's employees are committed to serving the healthcare professionals and their patients in more than 100 countries.
This organisation covers Medical equipment, instruments that are used in operating theatres. The ideal incumbent will be responsible for maintaining awareness and effectively communicating information on all relevant changes in Regulatory Authority Guidelines in the region to relevant groups within the company. You will also be responsible for keeping abreast of developments in regulatory guidance/requirements and determine their potential effects on activities in the region.
You will Lead and develop personnel to promote correct compliance with all regulations, laws or guidance. Provide Regulatory guidance and input to internal product review boards, working with external regulatory authorities as required to ensure appropriate input into regulatory strategy and plans. The Regulatory Affairs Director acts as regulatory responsible person for the development of global regulatory product strategies for the key projects/products as appropriate. You will manage the performance management process and career development program for supervised regulatory personnel. You will also motivate and develop a regulatory team that support the personal growth and culture of compliance.
A Successful candidate must have strong capability to manage, lead and support a collaborative team environment as well as leading a multidisciplinary team. Knowledge of surgical devices and their regulations. Must have a strong business acumen experience working within a regulatory environment. Proven analytical skills, ability to proof read and check documentation within a regulated environment; have knowledge of labelling, change control, operations promotion and advertising. You must have experience in conducting scientific and regulatory research, knowledge of general regulatory requirements. Have a depth of understanding of healthcare environment and ability to work independently showing the ability to demonstrate initiative and attention to detail, good problem solving skills is vital and the ability to work to deadlines across multiple simultaneous projects.
You must hold a US Passport or have the right to work in the United States of America work permit.
If you want to be a part of this exciting opportunity, Please contact Ekta Multani, Medical Devices Recruitment consultant at Paramount Recruitment on + 44 (0) 121 616 3474.
Keywords: Global Regulatory Affairs Director, Regulatory Director, Medical Devices, ISO 13485, FDA, 21 CDR Part 820 jobs, California, Orange County, research, 510k, Auditing, Medical Technology, Medical Information, , Regulatory Submissions, Quality Management systems, QMS,RA, American Citizen, labelling, surgical products
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