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
Education
Bachelor’s degree required
Master’s degree preferred
Experience
Minimum of 3 years of experience in regulatory affairs
Skills
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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