Remote - Onsite preferredDescription:Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products.This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.The incumbent will perform other duties assigned.Track of status and progress of regulatory documentationReview, edit and proofread regulatory documentationAssist in preparation and review of labeling, SOPs, and other departmental documentsCompile under supervision regulatory documents for submissionParticipate as an active team member of project teams as required,Compile and prepare responses to regulatory authorities questionsMaintain regulatory files in a format consistent with requirementsMaintain awareness of regulatory requirementsMay be responsible for a specific product portfolio in the region To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.List knowledge, skills, and/or abilities required.Scientific knowledgeWritten and verbal communication skillsKnowledge of regulationsTechnical systems skills (e.g. word processing, spreadsheets, databases, online research)Proofreading and editing skillsAbility to contribute to multiple projects from a regulatory affairs perspectiveAbility to multitask and prioritize Include the education and experience that is necessary to perform the job satisfactorily. Bachelor's degree in engineering or related scientific discipline with 2-4 years regulatory experience, preferably within a healthcare environment.EU MDR Experience PreferredNotes:Remote - Onsite preferred8am-5pm (flexible)VIVA is an equal opportunity employer. All qualified applicants have an equal opportunity for placement, and all employees have an equal opportunity to develop on the job. This means that VIVA will not discriminate against any employee or qualified applicant on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
Description:Under general supervision responsible for the coordination and the preparation of documents/packages for regulatory submissions. Review and evaluate technical and scientific data and reports required for submission in support of companies products.
This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work.
The incumbent will perform other duties assigned.Track of status and progress of regulatory documentationReview, edit and proofread regulatory documentationAssist in preparation and review of labeling, SOPs, and other departmental documentsCompile under supervision regulatory documents for submissionParticipate as an active team member of project teams as required,Compile and prepare responses to regulatory authorities questionsMaintain regulatory files in a format consistent with requirementsMaintain awareness of regulatory requirementsMay be responsible for a specific product portfolio in the region To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
List knowledge, skills, and/or abilities required.
Scientific knowledgeWritten and verbal communication skillsKnowledge of regulationsTechnical systems skills (e.g. word processing, spreadsheets, databases, online research)Proofreading and editing skillsAbility to contribute to multiple projects from a regulatory affairs perspectiveAbility to multitask and prioritize Include the education and experience that is necessary to perform the job satisfactorily. Bachelor's degree in engineering or related scientific discipline with 2-4 years regulatory experience, preferably within a healthcare environment.EU MDR Experience PreferredNotes:Remote - Onsite preferred8am-5pm (flexible)
(Please ensure email matches your resume email)
(document types allowed: doc/docx/rtf/pdf/txt) (max 2MB)
By submitting this form, you are consenting to the VIVA team contacting you via Phone/Email