This is Vydehi from Intellectt Inc. We currently have an opening for a Regulatory Affairs Project Leader with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at +1 732 355 7412.
Role: Regulatory Affairs Project Leader
Location: Santa Clara, CA
Duration: 12 Months on W2
Responsibilities
RA Lead / Core Team Support for manufacturing related submissions
RA Lead / Core Team regulatory support for international submissions and renewals
Provide regulatory support for change management activities, including RA impact assessments in Change Requests, Submissions, and approval of change orders to implement approved changes.
Review and approval of product release process and addendum labelling
RA project team member for new quality system process changes and updates
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.
Skills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance(FDA)