Regulatory Affairs Consultant

Regulatory Affairs Consultant
3 months contract to start
Orlando FL


Description:
Experience: Minimum 8 years professional experience in the applicable role. Education: Bachelor's /Master's degree or equivalent. Demonstrated capability and experience in role. Supports regulatory compliance performing the required activities that assure compliance with FDA regulations for class III products. Is a subject matter expert in RA for new products, familiar with product clearances, establishing licenses, maintaining files, communicating changes, evolving regulatory landscape, quality system procedures. May handle or support regulatory requests from regulatory agencies, prepare and submit product registrations and submissions to FDA and other regulatory bodies, maintain registrations and device listings, support the reporting of departmental metrics, support and backup for other Q&R functions, supports internal/external audits and regulatory inspections. Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives. Develop and prepare product registration submissions for the US, Canada, EU and select worldwide locations. Review and approve engineering changes, advertising, promotional items and labeling for regulatory compliance. Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project, Provide significate regulatory support to ongoing PMA activities

Thanks & Regards, 
Imran (Emu) Shikalgar 
APN Software Services, Inc 
39899 Balentine Drive, Suite 385, Newark, CA 94560 
510-402-4704 (Voice & Text) 
Phone: 510-623-5050 Extn.129 | Fax 510-623-5055 | Imran@apninc.com 
linkedin.com/in/imranshikalgar

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