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Job Opportunity for role Regulatory Specialist in Santa Clara CA

In California United States

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Job Opportunity for role Regulatory Specialist in Santa Clara CA

JOB TITLE:

Job Opportunity for role Regulatory Specialist in Santa Clara CA

JOB TYPE:

Full-time

JOB LOCATION:

Santa Clara California United States

JOB DESCRIPTION:

Hello.

We have a requirement for Regulatory Specialist for one of our medical devices client.
If you're interested in this position, drop me your updated resume to narayana@intellectt.
com or you can reach me at 732 769 3774

Role: Regulatory Specialist
Location: Santa Clara, CA
Duration: 12 Months
Shift Timings: 8am to 5pm

Job Description:

Responsible for implementing and maintaining the effectiveness of the quality system.

Provides consultation/advice to regulatory specialists for change control and product development.

Provides regulatory direction/interpretation on team activities.

Interprets and applies regulatory understanding to support of products and teams.

Handles regulatory activities involved in documentation, labelling, field support.

Applies regulatory and technical knowledge to a wide variety of complex work assignments.

Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports.

Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

This position will be providing support for the regulatory department to ensure efficient and compliant business processes and environment.

The individual may execute tasks and play a consultative role by partnering across business functions and suppliers.

The individual may assist in identifying data needed, obtaining these data and ensuring that they are effectively presented for the registration of products worldwide.

Skills:

Have working knowledge in EU MDR
Have working knowledge in Regulatory Change Assessment
Have working knowledge in US and EU medical device submissions
Knowledge of regulations and standards affecting IVDs and/or biologics

Year's of Experience:

2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function
Must have 3-5 years of experiences in Medical Device Regulatory Affairs

Education:

Bachelor's degree in Science, Math, Engineering or Medical Fields preferred.
BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.

Best Regards

NARAYANA JANAPARAPU | Healthcare Recruiter

narayana@intellectt.
com

linkedin: https://www.
linkedin.
com/in/narayana-janaparapu-852780225/

Direct: +1 (732)-769-3774 | Ext: 265

Office: +1 732 412 6999

Address: 517 Route 1 South, Suite 1115 Iselin, NJ 0880

_____________________________________________

You can reach Kowshik (Lead) | +1 (732) 627-1210 or kowshik@intellectt.
com while I'm away.

Position Details

POSTED:

Nov 23, 2023

EMPLOYMENT:

Full-time

SNAPRECRUIT ID:

S24947-10427-11162023-39440820

LOCATION:

California United States

CITY:

Santa Clara

Job Origin:

CEIPAL_ORGANIC_FEED

Job Opportunity for role Regulatory Specialist in Santa Clara CA Apply

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Hello.

We have a requirement for Regulatory Specialist for one of our medical devices client. If you're interested in this position, drop me your updated resume to narayana@intellectt.com or you can reach me at 732 769 3774