This is Basheer from IntellecttINC. We have an opening for a Regulatory Affairs Project Leader with one of our Medical Device Clients located in Santa Clara, CA. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to [email protected].
Role: Regulatory Affairs Project Leader
Location: Santa Clara, CA - 95054-2807
Duration: 12 Months on W2
Notes
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 processes in order to review and assess proposed product changes within the change management system (in Change Orders and Change Requests).
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 labeling
RA project team member for new quality system process changes and updates
Job 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 18 at Abbott.
Skills: Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA) Duties