Name of Client:HireGenics/TapFin/Abbott Laboratories
Contractor Primary Contact Person: BeatriceOgembo
CommencementDate: 13 July 2020
Completion Date:12Feb 2021
Directs activities related to business development, growing and sustaining GMDRC offerings involving the regulatory environment for medical devices with an emphasis in regulatory strategy development for clients, based on preclinical, clinical and post-market regulatory requirements. Provides input for regulatory strategies and requirements for medical device products to ensure appropriate regulatory strategy and timely, accurate regulatory submissions for clients.
Directs all activities related to business development, growing and sustaining company offerings involving the regulatory environment for medical device products with an emphasis in biocompatibility testing. Performs overall preclinical / regulatory strategy development for clients. Facilitates APS business development activities. Provides scientific / technical oversight of biocompatibility related activities. Provides input for regulatory strategies and requirements on medical device products internally and with clients to ensure appropriate regulatory strategy and timely, accurate regulatory submissions.
Collaborated with the St. Jude regulatory staff in the preparation of an original PMA (traditional) for expansion of an indication for use for a 510k cleared product. Responsibility included but not limited to the following PMA sections; device manufacturing (quality systems and software), animal studies summary, proposed labeling, referenced performance standard/voluntary standard, environmental assessment under 21 CFR 25.20(n) ((d)(i) or (ii), pediatric use - per 515A(a)(2) of the FD&C Act, statements/certifications/declarations of conformity, issues identified by FDA prior to PMA submission. Participated in cross-functional product development and manufacturing project teams. Provided guidance to project team on content for the PMA submissions for assigned sections. Perform other duties and projects as assigned by Manager, Regulatory Affairs.
Client:ValidantandSt. Jude Medical
Project Title: Project Manager, RA
CommencingDate: Sep 2017
Completion Date: Dec 2018
Location: Abbott (SJM) CRM – Sylmar, CA
Assist Client with both US and EU product submissions for CRM product.
Collaborated with Natus Medical in-country affiliates and distributors in the registration of Natus Medical products and maintenance of approvals in Latin America countries, Australia, Eastern Europe, Canada, Malaysia, Taiwan, Japan, China, and Indonesia
Client: Natus Medical
Role: International Regulatory Affairs Manager
Commencing Date: 2 January 2019
Completion Date: 30 June 2019
Project Length: 6 months
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