Advanced Regulatory Affairs Officer

2 weeks ago


South San Francisco, California, United States R&D Partners Full time

R&D Partners is in search of a Senior Regulatory Affairs Consultant.

Key Responsibilities:

  • Support ongoing marketed products by reviewing engineering modifications, promotional materials, labeling, and documentation to ensure compliance with both US and international regulatory standards.
  • Draft and maintain product technical files while overseeing compliance with global regulatory directives and regulations.
  • Manage submission processes for various device regulatory approvals, including IVDR/CE mark, US premarket approvals (PMAs), and post-approval reports.
  • Analyze and communicate product-specific regulatory issues to leadership that may significantly affect business operations.
  • Engage with regulatory authorities on technical and regulatory matters as necessary.

Qualifications:

  • Bachelor's degree in a scientific or engineering discipline; advanced degree is preferred.
  • Regulatory Affairs Certification is advantageous.
  • A minimum of 5 years of experience in regulatory affairs, particularly in IVD or medical devices.
  • Proficiency in Microsoft applications and general PC operations is essential.
  • Experience with regulatory submissions, including IVDR CE submissions, IDE, 510(k), and PMA submissions is highly desirable.

Why Join R&D Partners?

As a valued employee, you will enjoy a comprehensive benefits package that includes:

  • Medical insurance options – PPO, HMO & HSA
  • Dental and Vision coverage
  • 401k retirement plan
  • Employee Assistance Program
  • Long-term disability coverage
  • Weekly payroll processing
  • Expense reimbursement opportunities
  • Online timecard management

Compensation:

  • Salary range: $117,998 – $156,000 (Dependent on Experience)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research, and engineering sectors. We offer career opportunities within leading pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.

R&D Partners is an equal-opportunity employer.



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