Regulatory Affairs Project Leader

Spectraforce

Santa Clara, California


12 days ago

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Regulatory Affairs Project Leader
Spectraforce
Santa Clara, California

12 days ago

Job Description

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.  

About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
 
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.

Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $60.00/hr.