Job Details

  • Title: Regulatory Affairs Manager
  • Code: RCI-5088
  • Location:
  • Posted Date: 09/14/2020
  • Duration: 12 Months
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  Job Description

Years’ Experience: 7+ Skills:

  • Experience with Software as a Medical Device (SaMD).
  • Builds strategic partnerships to further departmental and organizational objectives.
  • Demonstrates effective change leadership.
  • Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
  • Some experience with regulatory cybersecurity requirements preferred.
Education:
  • Bachelor's degree and 7+ years of related work experience or an equivalent combination of education and work experience.
  • Advanced degree preferred.
Duties: 
  • Develops and executes organizational and operational policies that affect one or more groups by utilizing technical/professional knowledge and skills.
  • Assist with maintenance of the quality management system.
  • Prepare, contribute, plan and/or manage the preparation of post-market surveillance plans and evaluate post-market data.
  • Assist with revisions to company policies and procedures to ensure compliance.
  • Coordinate activities related to domestic and international regulatory submission and approval for medical software solutions.
  • Assess proposed regulations and communicate new requirements to the organization.
  • Develop regulatory strategies, approval schedules, and submission standards to achieve departmental and organizational objectives.
  • Monitor compliance of company policies and procedures to international regulations (FDA QSR, EU MDR, etc.).
  • Support the product development teams in the implementation of regulatory requirements, including review of design and test documentation.
  • Prepare, contribute, plan and/or manage the preparation of HFE and Clinical Evaluation deliverables.
  • Stay abreast of current and novel developments in the field.
  • Demonstrates effective change leadership.;