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Job Description: Vitalograph is a leading manufacturer of medical respiratory diagnostic devices and software, used in the diagnosis of respiratory disorders, and advanced high-reliability equipment and software systems used in respiratory end-point clinical drug trials. We have designed, developed, and manufactured respiratory diagnostic devices, software, and consumables for healthcare professionals for 60 years.
Headquartered in the UK, Vitalograph has operations in Ireland, Germany, and the USA. We are now recruiting for a Regulatory Affairs Specialist who can be based in our Ennis office. Reporting to the Regulatory Affairs Team Lead, you will be responsible for compiling documentation for the registration of Vitalograph’s Medical Devices with Global Authorities.
Why Join Us?
* Impact Lives – Your work contributes to medical breakthroughs and helps patients breathe easier.
* Career Growth – Clear development pathways to advance your skills and expertise.
* Keep Learning – Educational Assistance Programme to support your professional development.
* Great Benefits – Private Health Insurance & Pension Contributions.
Key Responsibilities
* Perform submittals to global Authorities following required formats.
* Manage project stages and requirements for each jurisdiction, including finance, localization, and approvals.
* Follow up on feedback from Authorities on applications.
* Create file structures for primary formats (ToC, CDST, ASEAN, STED, etc.) on the company server.
* Maintain SOPs and related documents to reflect registration processes and regulatory requirements.
* Collaborate with RA QA team on related duties.
* Liaise with other teams to gather necessary documents and data for registration.
* Support compliance and QMS activities as needed.
Minimum Requirements
* Third-level qualification (Level 6 or higher) in Science, Mechanical or Electronic Engineering, Quality/Regulatory discipline, or proven experience in quality/regulatory assurance within a regulated industry.
* Proficiency in English, both oral and written, with strong attention to detail.
* Experience supporting FDA or Notified Bodies audits is advantageous.
Key Skills
* Data analysis and synthesis.
* Project planning and organizational skills.
* Interpersonal and communication skills.
* Understanding of risk and scientific reasoning.
* Time management and organizational skills.
* Report and documentation presentation skills.
* Proactive and able to work independently and as part of a team.
Additional Details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Administrative
* Industry: Medical Equipment Manufacturing
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