Commercial Regulatory Affairs Lead with 10 years experience in a regulated medical device or pharmaceutical company required by market-leading Irish medical devices company in Galway.

This is a new role created as a result of global expansion. Based at headquarters in Galway, you will be responsible for leading the Commercial Regulatory Affairs team, collaborating with the commercial team on commercial strategy & working closely with the Engineering and Operations team on commercialisation aspects following regulatory approval.

Requirements: 

  • 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
  • Ability to effectively lead the Commercial Regulatory Affairs department with integrity to meet objectives while working collaboratively across departments in a strong growth phase
  • Excellent verbal and written communication, planning and co-ordination skills including strong presentation skills
  • Ability to demonstrate good business acumen, an understanding of business requirements, identification of and mitigating risks, managing change and working with business partners
  • Highly collaborative, team-work orientated and solutions driven with an innovative outlook
  • Strong understanding of strategic alignment and effective organisation and co-ordination skills
  • Ambitious role model who will enjoy inspiring their team and wider teams to achieve goals and objectives

Key Responsibilities:

  • 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 submissions
  • Support the integration partners to ensure they successfully register the product incorporated into their equipment
  • Support the R&D, Operations and Manufacturing Teams through the stage gates of the new product development process & for sustaining changes
  • Support on site audits, internal and external
  • Provides inputs to management review
  • Ensure compliance to global regulatory requirements

Please send cv in confidence to emer@emtechrecruitment.ie

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