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Regulatory Affairs Project Leader
2 weeks ago
Title: Regulatory Affairs Project LeaderLocation: Santa Clara, CA, 95054 USADuration: 12 MonthsJob Description:Education:Bachelor's degree required, Masters degree preferredExperience:Minimum of 3 years experienceSkills:Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)Duties:Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel.Communicates issues to management through project management tracking and issue briefings.Position is highly visible to internal and external stakeholders.High level of effective verbal and written communication skills must be demonstrated, including ability to negotiate, influence, and manage conflict.Prior regulatory experience in the medical device, food, dietary supplement or pharmaceutical industry is strongly preferred, but not required.Ability to work constructively, decisively, and collegiality with internal customers (scientists, marketing, quality assurance, product development, affiliates) to solve problems and communicate regulatory needs.Ability to manage and track broad and strategic projects.Ability to communicate effectively in writing crisp briefings and issue analysis.Demonstrated ability to work effectively in a team environment.Responsible for tracking and timely completion of regulatory strategies and issues, scientific substantiation for product claims, and label/promotional material activities.Responsible for effective communication of regulatory requirements to project teams and internal customers.Additional notesMust have RA submission experience. and EU & MU submissions experiencegood writing and communication skills - Word, ExcelBachelor's degree in engineering or science and a minimum of 3 years of experience of regulatory affairsDay to dayRegistrations - will train to do thisup to 200 pages of documentation formattingcomplete technical documents for different Countries and submit to government agencies as well as the US.#J-18808-Ljbffr
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Regulatory Affairs Project Leader
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Regulatory Affairs Project Leader
2 weeks ago
Santa Clara, United States TalentBurst Full timeTitle: Regulatory Affairs Project Leader Location: Santa Clara CA Duration: 12 monthsDescription: The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system. The position requires that they develop an understanding of the Clip products and manufacturing...
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Santa Clara, California, United States DivIHN Integration Inc Full timeJob DescriptionJob DescriptionFor further inquiries regarding the following opportunity, please contact one of our Talent Specialists Divya | Rashi | Title: Regulatory Affairs Project LeaderLocation:Santa Clara, CADuration: 1 YearDescription:Exempt/Non-Exempt: Non-exemptEducation: Bachelor's degree in engineering or scienceExperience: Minimum of 3 years of...
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1 week ago
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Regulatory Affairs Project Leader
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Regulatory Affairs Project Leader
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Regulatory Affairs Project Leader
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Regulatory Affairs Project Leader
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Santa Clara, United States Select Source International Full timeJob DescriptionJob DescriptionJob Title: - Regulatory Affairs Project LeaderLocation: - Santa Clara, CA 95054Duration: - 12 Months of Contract, with possibilities of extension. The candidate will assist in various regulatory duties including completion of deliverables and preparation of...
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Regulatory Affairs Project Leader
1 week ago
Santa Clara, United States Select Source International Full timeJob Description Job Description Job Title: - Regulatory Affairs Project Leader Location: - Santa Clara, CA 95054 Duration: - 12 Months of Contract, with possibilities of extension. The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system. The position...
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Regulatory Affairs Project Leader
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Santa Clara, United States Collabera Full timeJob DescriptionJob Description· Education: Bachelor's degree required, Master’s degree preferred· Experience: Minimum of 3 years of Regulatory Affairs experience· Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or...
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Regulatory Affairs Project Leader
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Santa Clara, United States Collabera Full timeJob DescriptionJob Description· Education: Bachelor's degree required, Master’s degree preferred· Experience: Minimum of 3 years of Regulatory Affairs experience· Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or...
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Santa Clara, United States Collabera Full timeJob DescriptionJob Description· Education: Bachelor's degree required, Master’s degree preferred· Experience: Minimum of 3 years of Regulatory Affairs experience· Skills: Knowledge of US and/or Canadian regulations or with EU and other international medical device regulations relating to product and/or...
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Regulatory Affairs Project Leader
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Santa Clara, California, United States Spectraforce Technologies Full timeTitle: Regulatory Affairs Project LeaderLocation: Santa Clara, CA, 95054 USADuration: 12 MonthsJob Description:Education:Bachelor's degree required, Masters degree preferredExperience:Minimum of 3 years experienceSkills:Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)Duties:Assists in definition/implementation of...
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Regulatory Affairs Project Leader
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Santa Clara, United States Planet Pharma Full time1-Year Contract $50-$52/hour Duties: Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate personnel. Communicates issues to management through project management tracking and issue briefings. Position is highly visible to internal and external stakeholders. High level...