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Contact Info
James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Director of Regulatory Affairs


Reference:JCA02804 Location: Dublin
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Regulatory Affairs Manager

Our client a high potential medical device start up is currently seeking a Director of Regulatory Affairs to join their team. Reporting to the CEO the Regulatory Affairs Director will be Responsible for leading the Regulatory strategy and submissions, in multiple jurisdictions, to progress Clinical and Regulatory approvals through to a fully developed, market approved device.


Role/Responsibilities

  • Provides Regulatory leadership for the development and clinical teams.
  • Develops innovative and effective worldwide Regulatory strategies for the product roadmap.
  • Provides guidance, direction, and leadership on those strategies to the Management teams and Board of Directors.
  • Drives efficiencies for Regulatory approvals of the product roadmap. Ensuring Regulatory plans are robust through identification and assessment of potential program risks.
  • Leads the preparation and successful approval of technical files/submission packages to FDA, Notified Bodies and Competent Authorities. Engages Regulators, where necessary, in oral and written communications to discuss pending or new submissions, Regulatory requirements, and to address questions.
  • Leads interactions with the FDA, and other Regulatory agencies, to guide products through efficient Regulatory approval in multiple jurisdictions.
  • Monitors the development of new Regulatory requirements or guidance documents and advises product teams of the impact on the business or development programs.
  • Conducts assessments such as Regulatory gap analyses, considerations and strategy, risk planning and mitigation. Clinical
  • Provides Regulatory input to clinical strategies to ensure efficient execution of key Clinical objectives
  • Supports Clinical activities and Clinical Regulatory approvals to ensure efficient trial approvals and execution.
  • Provides Regulatory review of study protocols, investigator’s brochures, labelling, and integrated summary documents.
  • Collaborates with Regulatory agencies to develop global approval strategies and synergies where possible. Management
  • Excellent project management skills. Creative approaches to reducing project risks and shortening timelines while delivering on business objectives.
  • Demonstrates collaborative leadership, being able to work across multiple functions.
  • Formulates and implements a strategy to best utilize in-house, contract, and outsourced Regulatory resources. Director of Regulatory Affairs
  • Creates a strong team working environment with focus on innovation, robust technology and meeting Regulatory requirements.
  • Manages external partners as necessary to support Clinical and Regulatory activities.
  • Develops and maintains effective working relationships with internal and external stakeholders who can support the Regulatory pathways.
  • Supports day to day management of the organisation.
  • Ensure interactions with colleagues/stakeholders fully reflects the company values:


Education and Experience

  • B.S. in science, engineering, or related field
  • Proven track record in a similar role with a minimum of 10 years in medical devices
  • Significant experience with FDA interactions and submissions required, EFS experience preferred.
  • Class III medical product development experience, involving clinical trials highly preferred
  • Cardiovascular and structural heart experience highly preferred
  • Deep and current understanding of FDA and ISO requirements, with the ability to interpret these requirements and implement them into a lean compliant product
  • In depth knowledge of the EU Medical Device Directive and MEDDEV guidance documents
  • Strong problem-solving mindset
  • Strong leadership, people and project management skills with the ability and willingness to effectively build and manage a small team. Experience in people management and development.
  • Excellent verbal and written communication skills
  • At ease in start-up environment and effectiveness to deliver in low-structured environments. Availability to travel is required



For further information please contact James Cassidy [email protected] or call in confidence 0860204322