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Chief Regulatory Officer

Company: Eitan Medical
Location: San Diego
Posted on: February 24, 2021

Job Description:

We are excited to offer the role of Chief Regulatory Officer (CRO) to be based remotely. This role will be part of the Regulatory Affairs globally at Eitan Group.CRO Responsibilities

  • Implementation of the regulatory strategy, risk management and continuous improvement projects to achieve business objectives.
  • Review and advise on all material FDA and global regulatory submissions/or registration strategies for product approvals or clearances. Review and approval of all FDA, NB requests and other regulatory agency inquiries.
  • Review and advise the management on product risk assessments and global change assessments.
  • Oversee risk management activities that can impact registration or business growth strategies of the business.
  • Build a team with capabilities to support the short-, mid- and long-term goals of the company.
  • Developing regulatory strategies and tactics, including building external partnerships, designed to achieve global product clearances and approvals faster and in compliance with relevant regulations and law. Actively participates on the RA Leadership team and regulatory trade associations operation projects, among other things.
  • Partners with Quality to ensure policies and procedures align with the Eitan Group Quality System.-- Lead and/or facilitate team preparation for regulatory agency/Health Authority meetingsLead and/or facilitate communications with global regulatory agencies
    • Lead, oversee and coordinate critical reviews and provide strategic input on regulatory filing documents.
    • Develop, define and lead internal growth and resourcing strategy for Global Regulatory Affairs within the organization the members of the regulatory affairs teams.Position Requirements:Education:
      • Bachelor of Science Degree in a Life Science or Engineering field is required
      • Advanced degree preferred (MS, PhD, MBA)Requirements:
        • Minimum of 10-15 years of medical device and/or pharmaceutical experience, directly working on regulatory filings required
        • At least 7 years of direct management
        • Recent experience leading meetings with FDA/CDRH for new device products - a Must
        • RAC certified a plus, but not required.-- Global regulatory experience combined with a desire to learn, investigate, and research global regulations, guidance's and industry standards-- Thorough understanding of medical device and combination product associated national regulations, and general knowledge of international regulations. Demonstrates in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes. Recognized internally as subject matter expert in multiple areas-- Strong verbal and written communication skills-- Independently authors written reports/documents for distribution within division.-- Recognizes potential problems and proposes solutions-- Assesses potential impact and/or applicability to other related areas within unit and business.-- Assesses corrective action to assure it prevents recurrence.-- Able to confidently deal with ambiguous issues and provide input towards suitable actions.-- Suggests significant opportunities for improvement (cost, cycle time, quality, etc.) that are complex or involve multiple organizational areas.-- Analyzes feasibility and participates in developing, executing, or monitoring implementation plan.-- Manages and monitors multiple complex and diverse projects simultaneously, including projects that involve several functional areas.Special Skills:-- Ability to link regulatory strategy, tactics, and outcomes to business strategy-- Ability to create and sustain a results-oriented culture-- Strong business acumen-- Ability to influence through effective communication, people management, and leadership skills.-- Ability to work independently and proactively-- Ability to work effectively in a cross-functional teamComplexity of Duties:-- Working in a matrix, across organizational boundaries and within ambiguous environments.-- Works on complex issues in a cross-cultural business environment.-- Ability to manage multiple priorities at the same time.-- Must operate with a sense of urgency.-- Ability to travel domestic and internationally as necessary Personality:-- A team player-- Ability to multi-task and work well within a dynamic, fast-paced organization-- Organized, paying attention to the small details

Keywords: Eitan Medical, San Diego , Chief Regulatory Officer, Executive , San Diego, California

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