Director of Regulatory Affairs

Our client a global medical device companywho have established a European Centre of Excellence in Ireland are currently seeking a Director of Regulatory Affairs to join their team. The Director of Reg Affairs will support worldwide regulatory submissions and audits outside of USA. The Director of Regulatory Affairs will report to VP of International Operations and will be a dynamic, detail-oriented, self-directed contributor and will spot opportunities to develop and optimize regulatory strategy while managing multiple projects and priorities. The Director of Regulatory Affairs will be responsible for planning, compliance, and documentation EU MDR, and other applicable country regulations.


Role/Responsibilities:

• Provide timely notification of document changes (e.g., ISO 13485 Certificate) to the appropriate health authorities.
• Review and ensure that all product labelling complies with applicable regulatory requirements,
• Review and ensure that the company website and marketing collateral accurately reflect product descriptions, intended use, and specifications.
• Lead external audits with regulatory agencies, ensuring findings are documented, and corrective actions are effectively taken.
• Participate as the regulatory representative on product development teams.
• Participate in Risk Management and Risk Analysis reviews for all products.
• Perform duties as the regulatory management representative for company as per domestic and international regulations.
• Manage regulatory requirements and compliance for all companys locations
• Lead the team in the maintenance of our Clinical Evaluation Reports.
• Provide regulatory input into the study setup, including country feasibility and ensuring adherence to local requirements and legislation
• Ensure all agency correspondence and commitments are appropriately tracked and archived in accordance with companies procedures, or develop new procedures as necessary
• Collect, share and interpret emerging regulations, ensure alignment with clinical development and strategy
• Establish a Rapid Response Team as necessary to develop and obtain alignment on strategy for responses to regulatory authorities
• Exhibit ownership and accountability for projects and internal assignments
• Perform other work-related duties as requested, directed, or assigned by management.
• Manage a small team responsible for QA/RA across the organization, including internal Audits.

• Minimum of MSc or equivalent degree is required
• Advanced degree (PhD, MD or Pharm D) strongly preferred (Regulatory Affairs Certification (RAC) is a plus)
• Experience working with medical devices (ideally Class III).
• Experience leading or participating in notified body audits of medical devices.
• Experience with the ISO 13485 Medical Device Quality System.
• Knowledge of EU Medical Device Regulatory (MDR) requirements.
• Knowledge or familiarity with Statistical Process Controls (SPC).
• Experience in maintaining EU Technical Files for CE marking compliance.
• Familiarity with FDA Good Manufacturing Practices (GMP).
• Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS) is preferred.
• Experience managing QA/RA in an Agile Software Development Environment.
• Ability to work independently, self-directed.
• Excellent interpersonal, organizational, communication, and presentation skills.
• Optimistic, positive, can-do attitude and high energy approach.