Exempt / Non-Exempt : Non-exemptEducation : Bachelor's degree required, Masters degree preferredExperience : Minimum of 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.Equivalent to Grade at .
Regulatory Affairs Project Leader
Responsible for effective communication of regulatory requirements to project teams and internal customers. Minimum of 3 years experience in regulatory affairs. Assists in definition/implementation of regulatory strategy and priorities in conjunction with management, peers, commercial, and affiliate...
Regulatory Affairs Project Leader
Job Title:- Regulatory Affairs Project Leader. The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system. RA Lead / Core Team regulatory support for international submissions and renewals. Provid...
Regulatory Affairs Project Leader
Responsible for effective communication of regulatory requirements to project teams and internal customers. Exempt/Non-Exempt: Non-exemptEducation: Bachelor's degree required, Masters degree preferredExperience: Minimum of years experienceSkills: Knowledge of US and/or Canadian regulation relating t...
Regulatory Affairs Project Leader
Title:Regulatory Affairs Project Leader. Minimum of 3years of experience of regulatory affairs. Assists in definition/implementation of regulatorystrategy and priorities in conjunction with management peerscommercial and affiliate personnel. Communicates issues to management through projectmanagemen...
Regulatory Affairs Project Leader
The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system. Responsible for effective communication of regulatory requirements to project teams and internal customers. RA Lead / Core Team regulato...
Regulatory Affairs Project Leader
Responsible for effective communication of regulatory requirements to project teams and internal customers. The candidate will assist in various regulatory duties including completion of deliverables and preparation of regulatory submissions for the next-gen clip system. Exempt/Non-Exempt: Non-exemp...
Regulatory Affairs Project Leader
MsoNoSpacing"><b>Role: Regulatory Affairs Project Leader</b></p> <p class="MsoNoSpacing"><b>Location: Santa Clara, CA </b></p> <p class="MsoNoSpacing"><b>Duration: 12 Months on W2</b></p> <p class="...
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School of Medicine, Stanford, California, United States.Administration📅May 24, 2024 Post Date📅103389 Requisition #The .Division of Cardiovascular Medicine.Our division is driven by over 80 faculty, clinician educations and instructors who are the pillar of strength in the division’s ongoing ef...
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