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* Keeps abreast of US and international regulatory guidance/procedures and changes and performs Regulatory Intelligence ... Affairs Associates and provides additional direction to the Regulatory Assistant when needed Requirements * A strong and...
*Function as the primary contact with FDA and international regulatory authorities. *Provide regulatory guidance and ... the life sciences) with at least five years experience in regulatory affairs; experience with biological products...
at partnered meetings with regulatory agencies; primary regulatory representative to US and ex-US regulatory ... * Identifies Regulatory Affairs' SOP needs and discusses with site head/department...
to either a Senior Manager or an Associate Director. The Manager must represent or assist senior Regulatory Affairs ... Manager is responsible for assisting the Regulatory Affairs, Advertising and Promotion group in meeting...
documents for Regulatory submissions. Work closely with Regulatory and CMC staff to troubleshoot technical issues ... Work Experience A minimum of 3 6 years Regulatory Affairs experience, or equivalent related industry...
groundbreaking work. The Project Manager, Regulatory Affairs Manager develops and implements regulatory ... Develops IDE/510K/ and PMA submissions for class II and III medical devices. The Project Manager, Regulatory Affairs co...
Regulatory Affairs Specialist is responsible for developing regulatory strategy, preparing international regulatory ... * Work with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficienci...
Surgical Product Development Process. * Work directly with regulatory agencies on regulatory issues and submissions. * ... complex medical device experience acceptable * RAC (regulatory affairs certified) desirable * Combination...
Work closely with Regulatory/Clinical/CMC staff to troubleshoot technical issues related to regulatory submissions ... assigned. Work Experience A minimum of 3 6 years Regulatory Affairs experience, or equivalent related industry...
at partnered meetings with regulatory agencies; primary regulatory representative to US and ex-US regulatory ... with site head/department. * Drafts and reviews local Regulatory Affairs' SOPs and global medical...