Regulatory Affairs Manager with experience in the medical devices sector required for permanent role with medical devices multinational in Galway. 

Responsibilities:

  • Supervising the day to day workload and operational issues of the regulatory affairs team
  • Co-ordinate the day to day running of the regulatory affairs programmes in accordance with internal procedures and regulatory requirements
  • Maintains an excellent understanding of the global medical device regulations
  • Actively pursues ways in which to improve the function of the Regulatory Affairs Department
  • Ensure compliance to 21 CFR 820, ISO 13485, MDD, MDR, MDSAP, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
  • Provides regulatory leadership to development teams e.g. cross-functional alignment with issues of possible regulatory ramifications
  • Acts as a liaison with Quality, R&D, Legal, and Operations
  • Prepares submissions for device design changes and /or manufacturing changes
  • Reviews product and manufacturing changes for compliance with applicable regulations
  • Reviews protocols and reports to support regulatory compliance and submissions
  • Builds partnerships and mutual respect with regulatory authorities (e.g., FDA, Notified Body)
  • Uses project management experience to create timelines and provide deliverables for regulatory projects
  • Provides guidance to management on upcoming regulatory changes (Brexit, MDR,) and the impact of those changes

Requirements:

  • Level 8 Degree (BS, BA) (technical discipline preferred)
  • At least 5-7 years’ Regulatory experience
  • Understanding of MDR
  • Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results
  • Ability to work effectively within a team in a fast-paced changing environment
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
  • Ability to travel approximately 10%, including international

 

Please contact Emer Smith to discuss in confidence
00353578638188       
emer@emtechrecruitment.ie

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