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Regulatory Affairs Project Leader

3 months ago

Santa Clara, United States Spectraforce Technologies Full time

Job Title:- Regulatory Affairs Project Leader

Location:- Santa Clara, California, 95054

Duration:- 12 Months

Timings:- 8AM -5PM

Roles and Responsibilities:-

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). Specific responsibilities will include:

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

Education:-

Bachelor's degree required, Masters degree preferred

Minimum of 3 years experience

Knowledge of US and/or Canadian regulation relating to product and/or device clearance (FDA)Duties

CPRA:

The Company is committed to complying with the California Privacy Rights Act ("CPRA") effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com. #J-18808-Ljbffr