Senior Regulatory Affairs Specialist

Job Description

Job Description

Senior Regulatory Affairs Specialist

Location: Santa Clara, CA

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $64.75 / Hour (USD)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Key Responsibilities

• This position will be working with multiple business units to develop, update, and improve regulatory affairs processes.
• Assist with strategy implementation and operations for regulatory affairs activities, including directing development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
• Update and develop procedures for regulatory affairs to support changes in the regulatory landscape, including EU MDR. Identify opportunities for regulatory affairs processes and drive changes to completion.

Required Skills

• Have working knowledge of EU MDR.
• Have working knowledge of Regulatory Change Assessment.
• Have working knowledge of US and EU medical device submissions.
• Have experience supporting internal and external inspections.
• Work cross-functionally and in a matrixed environment.
• Have experience with continuous improvement activities.

Education Requirements

• Bachelor's Degree required.

Required Experience

• Must have 3 5 years of experience in Medical Device Regulatory Affairs.

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About the Client

This global healthcare innovator has operated for more than 140 years, developing life-changing medical devices, diagnostics, nutritional science, and pharmaceutical products that reach patients in more than 160 countries. The organization's portfolio spans cardiovascular care, diabetes management, diagnostic testing, nutrition, and neuromodulation, with recognized brands that millions of people rely on every day. With operations across four major business segments medical devices, nutritional products, diagnostics, and established pharmaceuticals the company employs biomedical engineers, clinical scientists, regulatory affairs specialists, and commercial operations professionals who collaborate across cross-functional, international teams. A certified Great Place to Work, 80 percent of employees report it is a great place to work, well above the national average.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-16923 Industry: Manufacturing & Operations

#LI-Onsite #LI-GTT #gttjobs

\nCompany Description

Global Technical Talent is a subsidiary of Chenega Corporation ( with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.

We are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.




There is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link:




Awards

SIA’s Fastest Growing Staffing Firm: 2023 and 2015
SIA’s Best Staffing Firm to Work for: 2019 -2023
Inc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015
Randstad Preferred Supplier: 2020 - 2023
TechServe Alliance Excellence Award. 2019
NH Business Magazines Fast 5 fastest growing companies
Ernst & Young Entrepreneur of the Year Finalist: 2015

Company Description

Global Technical Talent is a subsidiary of Chenega Corporation ( with over 1.3 billion US$ in revenue and 5800 US employees. We provide Total Talent Solutions, Global staffing, SOW, RPO, Direct Sourcing, and Global Payroll with physical offices in US, Canada, and India. GTT Digital headquartered in Toronto specializes in providing high-tech digital and banking talent to some of the nation’s largest financial institutions. As a leader in the staffing industry for over 22 years, we have become one of the largest staffing firms in the New England region, working with Fortune 500 clients and cutting-edge, technology-driven recruiting infrastructure.\r\n\r\nWe are a Native American-owned, economically disadvantaged corporation that highly values diverse and inclusive workplaces. Our clients and partners are among the most successful and innovative organizations in the world. Our top clients are Fortune 500 banking, insurance, and financial services firms, some of the nation’s largest life sciences, biotech, utility, and retail companies, and prestigious educational institutions in the Ivy League tier.\r\n \r\nThere is always a new opportunity for success when you look through all of the open job opportunities on our website’s career page. Just click on this link: \r\n \r\nAwards\r\n\r\nSIA’s Fastest Growing Staffing Firm: 2023 and 2015\r\nSIA’s Best Staffing Firm to Work for: 2019 -2023\r\nInc 5000 Fastest Growing Private Company: 2023, 2022, 2016, 2015\r\nRandstad Preferred Supplier: 2020 - 2023\r\nTechServe Alliance Excellence Award. 2019\r\nNH Business Magazines Fast 5 fastest growing companies\r\nErnst & Young Entrepreneur of the Year Finalist: 2015