Senior Regulatory Affairs Specialist

7 days ago

Carlsbad, California, United States Entegee Full time

Job Title: Senior Regulatory Affairs Specialist

Company Overview

Entegee is a leading provider of custom automation solutions, specializing in controls and robotic technologies worldwide.

We are seeking an experienced Senior Regulatory Affairs Specialist to join our team. This role will be responsible for ensuring compliance with international regulatory requirements, coordinating submissions, and providing strategic guidance to the organization.

Estimated Salary

$50-$70 per hour

Job Description

This is a unique opportunity to leverage your expertise in international registration and global regulatory strategies to drive business growth and success.

  • Regulatory Compliance: Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections to ensure timely completion and accuracy.
  • Strategic Guidance: Provide expert advice on global regulatory procedures and changes, recommending updates to labeling, manufacturing, marketing, and clinical protocols for regulatory compliance.
  • Project Management: Lead or compile all materials required for submissions, license renewals, and annual registrations, ensuring seamless project execution.
  • Tracking and Control Systems: Monitor and improve tracking/control systems for regulatory submissions to maintain efficient workflows.
  • Candidate Interaction: Interact with regulatory agencies on defined matters, providing necessary documentation and responses.
Required Skills and Qualifications
  • Minimum 3 years of direct experience in international registration
  • 4-5 years as an independent Regulatory Affairs (RA) specialist in US/EU/Global registration
  • Proficiency in time management and project management
  • Experience with global regulatory strategies and collaboration with RA teams in different regions for product registration
  • Familiarity with medical device design control processes and coordination with design/manufacturing sites for additional documents required by global regulations
Benefits
  • A competitive hourly rate ($50-$70)
  • A comprehensive benefits package, including medical, dental, vision, life insurance, short-term disability, and commuter benefits
  • A generous paid leave policy, including Paid Sick Leave and Holiday pay
  • An Employee Assistance Program (EAP) and a 401K plan
Equal Opportunity Employer

Entegee is an Equal Opportunity Employer, committed to fostering a diverse and inclusive workplace. We welcome applicants from all backgrounds and perspectives.

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