Job Description
Vitalograph is the world’s 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. Headquartered in the UK, Vitalograph has operations in Ireland, Germany, and the USA. Our mission is to improve patient lives by designing and manufacturing market-leading products and services.
Why Join Us?
At Vitalograph, we offer more than just a job. As a global leader in medical respiratory diagnostics, you'll be at the heart of groundbreaking technology used worldwide to diagnose respiratory disorders. Here’s what you can expect:
* Pension contribution from the company, ensuring your future is secure.
* Private health insurance for peace of mind.
* Educational assistance programme to fuel your professional growth.
* Clear career development opportunities, with room to grow and make an impact.
The Role
Reporting to the Regulatory Affairs Team Lead, the Regulatory Affairs Specialist will take ownership of compiling the appropriate documentation for the registration of Vitalograph’s medical devices to global authorities.
Why Join Us?
* Impact lives – Your work will contribute to medical breakthroughs and help 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 for peace of mind.
Key Responsibilities
* Perform submittals to global authorities for devices using the required format.
* Project management of the overall submittal process stages and requirements for each jurisdiction, including finance, localization, and approvals.
* Follow-up on feedback from authorities on submittal applications.
* Create file structures for primary designated formats (ToC, CDST, ASEAN, STED, etc.) on the company server.
* Create and maintain Vitalograph SOPs and related documents to reflect changes in registration processes and regulatory requirements.
* Work with RA QA team on related duties.
* Liaise with other teams to develop or obtain necessary documents and data for registration.
* Perform other duties supporting compliance or QMS activities.
Minimum Requirements
* Third level qualification (level 6 or higher) in a Science, Mechanical or Electronic Engineering, Quality/Regulatory discipline, or proven experience in quality assurance or regulatory assurance within a regulated industry.
* High proficiency in English, both oral and written, including reading and understanding technical documentation, with strong attention to detail.
* Experience supporting FDA or Notified Bodies audits is advantageous.
Key Skills
* Ability to analyse and synthesise data.
* Good project planning and organisational skills.
* Strong interpersonal and communication skills.
* Scientific and logical mindset, with ability to discuss risks.
* Time management and organisational skills.
* High-quality report and documentation presentation skills, with effective clarification notation.
* Proactive and able to work independently while being a team player.
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