Senior Regulatory Affairs Specialist

Generis Tek Inc.

🇺🇸 United States
On-site
Senior
1 day ago

1 day ago

Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition SpecialistPriyanka Mahantat email address Priyanka.mahant@generistek.com can be reached on #(630) 576-1940.

We haveContractrole Senior Regulatory Affairs Specialistfor client atSanta Clara, CA.Please let me know if you or any of your friends would be interested in this position.

Position Details:
Senior Regulatory Affairs Specialist- Santa Clara, CA
Location                       : Santa Clara, CA – 95054
Project Duration      : 12 Months of contract
Shift Timing               : 8:00 AM to 5:00 PM (Mon to Fri)
Pay Rate                      : $62.00 per hour on W2

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

Years Experience:

Must have 3-5 years of experiences in Medical Device Regulatory Affairs

Skills:

Have working knowledge in EU MDR
Have working knowledge in Regulatory Change Assessment in
Have working knowledge in 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:

BA Degree Required

To discuss this amazing opportunity, reach out to our Talent Acquisition SpecialistPriyanka Mahantat email address Priyanka.mahant@generistek.com can be reached on #(630) 576-1940.

About generis Tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.

Senior Regulatory Affairs Specialist · Generis Tek Inc.

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