Sr. Regulatory Affairs Specialist

2 weeks ago

Palo Alto, United States Hired by Matrix Full time
Job DescriptionJob Description

Hybrid Role - Onsite 2D/Week


What You’ll Do:

  • Perform the coordination and preparation of regulatory submissions for brachytherapy devices and software devices according to regulatory requirements.
  • Identifies, analyzes and implements country specific requirements necessary for product related submissions.
  • Recommend strategies for earliest possible approvals for marketing applications.
  • Performs regulatory projects or acts as a member of the project steering group.
  • Submits required documentation/information to local authorities or Varian internal.
  • Initiates and escalates necessary activities if deviations are identified.
  • Ensures creation of adequate documentation for audits/inspections.
  • Performs training within the organization in country specific regulatory requirements, if applicable.
  • Write and maintain submissions procedures, work instructions and templates relevant for maintaining regulatory compliance.
  • Performs review of promotional material for regulatory compliance according to country specific requirements. 

What You Bring:

  • 5-8 years’ experience.
  • Product Registration Experience:
  • Experience with FDA 510(k) applications, Health Canada license applications and EU MDR technical files.
  • Knowledge of regulatory guidance documents and requirements for product classification determination, FDA 510(k) submissions, Health Canada license Applications and EU MDR technical files.
  • Knowledge of regulatory guidance documents (FDA, Health Canada, and EU MDR) for determining if a product change requires a regulatory submission (software and hardware devices).
  • Working knowledge of ISO 13485, IEC 62304, IEC 62366, ISO 14971, and ISO 10993-1 as evidenced by coursework or submissions that required use of each standard.
Company DescriptionHired by Matrix believes in the human touch and starts every partnership with an in-depth conversation. By talking with our clients about their hiring needs and listening to job seekers describe their career goals, we build an understanding of what they are looking for and work hard to make it happen.Company DescriptionHired by Matrix believes in the human touch and starts every partnership with an in-depth conversation. By talking with our clients about their hiring needs and listening to job seekers describe their career goals, we build an understanding of what they are looking for and work hard to make it happen.

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