Regulatory Affairs Specialist | Collins McNicholas

Regulatory Affairs Specialist

  • Reference: 45438
  • Job Type: Permanent
  • Location: Leinster, Offaly, Westmeath
  • Category: Science, Pharmaceutical & Food

Job Title: Regulatory Affairs Specialist

Responsibilities: 

  • Review and approve all related change orders and perform the necessary regulatory assessments, working with a larger regulatory team to determine pre-approval requirements. 
  • Supports the manufacturing of Class II (US), IIb and III (EU) electrical/mechanical medical devices and related components and accessories.  
  • Responsible for the development and maintenance of EU product files including Class III design dossiers and Class IIb, IIa and Is technical files which facilitates timely regulatory approvals.
  • Responsible for the development and implementation of global regulatory strategies based on US FDA regulations, European Medical Device Directive, External Standards, and other international regulations.
  • Perform analysis of complaints to determine if the incident is reportable under EU MDD/MDV requirements and completes MDV documentation for on-time filing. 
  • Prioritize regulatory workload based on compliance and business objectives, while working with management to make regulatory decisions that allow the company to achieve its goals while maintaining regulatory compliance.

Qualifications/Experience:

  • Bachelor’s degree (or equivalent international degree) with 3 years of experience or equivalent combination of education and experience in supporting manufacturing of medical devices.  
  • Proven skills in the developing CE registrations and US PMA/510(k) Premarket Notifications. Must also possess knowledge of US FDA regulations, ISO Standards, and European Medical Device Directive (MDD). 
  • Experience working with US FDA, European Notified Bodies and Competent Authorities and other regulatory agencies. 
  • Strong writing, data analysis, and communication skills and the ability to handle multiple demanding projects. 

For a confidential discussion and more information on the role, please contact David Lennon on 09064 78104 and email your CV to david.lennon@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie


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David Lennon

Contact Consultant

  • David Lennon
  • Recruitment Consultant
  • 0906478104
  • Connect with David

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