Regulatory Affairs Specialist
Regulatory Affairs Specialist
Intellectt Inc
Santa Clara, CA
See who Intellectt Inc has hired for this role
Hello
Hope you are doing well.
This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at +1(732)-276-1791.
Role: Regulatory Affairs Project Leader
Location: Santa Clara, CA - 95054-1208
Duration: 12 Months
Shift Timings: 8 am to 5 pm
Duties
Job Description:
Hope you are doing well.
This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at +1(732)-276-1791.
Role: Regulatory Affairs Project Leader
Location: Santa Clara, CA - 95054-1208
Duration: 12 Months
Shift Timings: 8 am to 5 pm
Duties
Job Description:
- Assist in defining and implementing regulatory strategy and priorities
- Communicate issues to management through project tracking and briefings
- Engage effectively with internal and external stakeholders
- Demonstrate strong verbal and written communication skills, including negotiation and conflict management
- Work constructively with internal customers (scientists, marketing, quality assurance, product development) to solve problems and address regulatory needs
- Manage and track broad, strategic projects
- Write clear and concise briefings and issue analyses
- Track and ensure timely completion of regulatory strategies, scientific substantiation for product claims, and label/promotional material activities
- Communicate regulatory requirements to project teams and internal customers effectively
- Bachelor’s degree required
- Master’s degree preferred
- Minimum of 3 years of experience in regulatory affairs
- Knowledge of US and/or Canadian regulations relating to product and/or device clearance (FDA)
- Familiarity with EU regulations and MDR Technical Documentation
- Experience with PMA, IDE, and 510(k) submissions
- Ability to prepare and submit products for international registration
-
Seniority level
Associate -
Employment type
Full-time -
Job function
Legal -
Industries
Medical Equipment Manufacturing
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