Due to the global expansion of their business, my client is currently recruiting for a newly created position of Commercial Regulatory Affairs Leader at our headquarters in Galway. The person will be responsible for leading the Commercial Regulatory Affairs team comprising of Senior Regulatory Affairs Specialists, Regulatory Affairs Specialists and Associate Regulatory Affairs Specialists. The role will collaborate with the commercial team ensuring the commercial strategy is supported and executed and work closely with the Engineering and Operations team on commercialisation aspects following regulatory approval.
Key responsibilities include
• Lead, develop, coach and mentor the regulatory team of senior specialists, specialists, and associate specialists.
• Support the team with their career develop plans.
• Ensure the team meet the goals and objectives set by the business.
Support the commercial strategy for the business:
• Attend the commercial regional meetings, representing the regulatory function.
• Provide inputs to the commercial meetings ensuring our commercial partners are kept informed of regulatory changes and challenges for specific countries and/or regions.
• Provide prompt and accurate advice to our commercial partners.
• Provide mitigation plans for risks that may be present in the business
• Ensure renewals are completed on time.
• Provide inputs to distributor agreements
• Ensure authorised representatives are established where required and provide inputs to those agreements.
• Confidentially communicate with regulators and/or local agents regarding the clients submissions.
• Ensure the client ships product to regulatory approved countries utilizing the ERP system for those controls.
• Provide inputs to the Integration Partners agreements.
• Support the integration partners to ensure they successfully register the clients product incorporated into their equipment.
• Support the marketing team with promotional material review and release.
• Ensure the materials follow regulatory requirements.
New Product Development:
• Support the R&D, Operations and Manufacturing Teams through the stage gates of the new product development process.
• Support the R&D, Operations and Manufacturing Teams through the stage gates for sustaining changes.
• Support on site audits, internal and external.
• Provides inputs to management review.
• Ensure compliance to global regulatory requirements.
Education and experience required
• Degree Level in Law, Engineering, Technology, or Science.
• Masters Degree Level in Regulatory Affairs or other similar discipline.
• 10 years’ experience in a regulated medical device or pharmaceutical company
• 3+ years in a managerial/leadership position in a regulated medical device or pharmaceutical company.
• Thorough understanding of global regulatory challenges and emerging regulations.
• Useability and electrical medical device experience is advantageous for this role.
• Excellent verbal and written communication, planning and co-ordination skills including strong presentation skills.