Regulatory Affairs Specialist
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 to diagnose respiratory disorders worldwide. 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 the 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 that Authorities required format.
- Project Management of the overall submittal process stages and requirements, for each jurisdiction with regard to all deliverables, including finance, localization, and approvals of documents, etc.
- Perform timely follow-up on feedback from Authorities on submittal applications.
- Create file structure for the primary designated formats (ToC, CDST, ASEAN, STED, etc) on the Company server.
- Create and/or maintain Vitalograph SOPs and related documents as needed, to reflect changes to the process of registration and general Regulatory requirements.
- Work with RA QA team in other related duties of that team.
- Liaise with other functional teams in development of and / or obtaining the necessary documents and data to fulfil registration requirements.
- Perform other duties as may be assigned in support of 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 the English Language, both oral and written, including the ability to read and conceptualise technical documentation, with strong attention to detail.
- Backroom experience in support of FDA or Notified Bodies audits would be advantageous.
Key Skills:
- Ability to analyse & synthesise data.
- Good project planning and organizational abilities.
- Strong interpersonal and oral / written communications skills.
- Good scientific and logical attitude, with ability to understand and discuss risk.
- Strong time management and organisational skills.
- Demonstrable high-quality report and documentation presentation skills, with effective clarification notation, noting primary review will be by 3rd party.
- Pro-active, with proven ability to work under own initiative, while being a strong team player.