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Regulatory Affairs (Medical Device) Specialist

Kforce Technology

This is a Contract position in Carlsbad, CA posted November 17, 2020.

RESPONSIBILITIES:

Kforce has a client that is seeking a Senior Regulatory Affairs Specialist in Carlsbad, CA. Summary: The Sr. Regulatory Affairs (Medical Device) Specialist provides regulatory counsel and strategy to cross-functional project teams. You will develop medical device regulatory plans and serves as lead author on regulatory submissions supporting product registrations in the U.S., EU, and other international jurisdictions. Supports business needs by reviewing Electronic Change Orders (ECOs) and Non-Conforming Material Reports (NCMRs), and participating in creating and/or updating department procedures. With management oversight, the position is expected to interact directly with FDA and international reviewers. Duties and Responsibilities:

  • Authorizes regulatory submissions to support FDA clearances/approvals, CE Mark, and other international medical device product registrations
  • Represents the Regulatory Affairs Department on cross-functional project teams, helping to maintain outstanding relationships with all key internal customers and regulatory agencies
  • Supports business needs by reviewing and approving changes to the Quality Management System
  • Develops and executes medical device Regulatory Plans to support new products and projects
  • Remains current in all applicable regulations and communicating new and revised regulations to the broader organization
  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors
  • Demonstrates sound judgment in selecting methods and techniques for obtaining solutions
  • Networks with more senior internal and external colleagues in own area of expertise
  • Determines methods and procedures on new medical device assignments and may coordinate activities of other colleagues with limited supervision
  • Responsible for compliance with quality system procedures and all regulatory requirements

Job Requirements:

REQUIREMENTS:

  • Typically requires a minimum of 6 years of related experience and a Bachelor’s degree in a related discipline, or equivalent combination of education and experience
  • Must have at least 3 years of experience writing and filing submissions with the U.S. FDA and/or EU Notified Bodies
  • Must have medical device experience
  • Must be skilled at managing a significant workload and obtaining positive results, taking on additional responsibility and managing priorities as needed
  • Must be accurate, detailed, committed to high quality standards and pro-active in finding solutions to achieve successful outcomes
  • Capable of following realistic plans, goal setting, resource management, contingency planning, coordinating and cooperating with others

Kforce is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.