Senior Regulatory Affairs Specialist

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

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