Regulatory Affairs Specialist

The Regulatory Affairs Specialist’s role involves working cross-functionally with clinical, quality, and engineering teams during the design process, test development, jurisdiction expansion, and product lifecycle. This includes a range of activities related to marketing authorization, submissions, vigilance, adverse event reporting, and clinical evaluation within the In-Vitro Diagnostics/Medical Device environment.

The primary function of this role is to support the management and maintenance of Regulatory Affairs requirements in the global jurisdictions in which LetsGetChecked operates, ensuring smooth and efficient processes. The Quality and Compliance team based in Dublin is responsible for global regulation, managing pre- and post-market regulation for various product classifications across Europe, the USA, and Canada.

Responsibilities and Duties

• Act as a contributing Regulatory Team member for assigned regulatory projects.
• Creation and review of SOPS, change control forms, CAPA/NCR process.
• Support role to Quality team.
• Support role in both Internal and External Audits, particularly ISO 13485:2016.
• Work as part of a multi-functional team by providing regulatory input to new product development, including artwork approvals, label claims, IFUs, and associated supporting documentation
• Reviewing product claims in social media and other marketing material
• Contribute to ensuring regulatory requirements are met in a planned and timely manner to avoid delays in approvals.
• Support the development and implementation of the Regulatory Strategy.
• Stay updated on US, EU, and other global regulatory guidelines.
• Build and maintain strong relationships with Regulatory Authorities, Consultants, and internal departments.
• Support the preparation of regulatory documents to EU competent authorities and the US FDA including device listings, establishment registrations, adverse event reporting, and substantial changes.
• Assist in the maintenance and compilation of EU IVDR and MDR technical files for in vitro diagnostic sample collection kits (IVD Class A) and Class IIa medical devices.
• Participate in Continuous Improvement Initiatives to enhance department functions.
• Actively participate and employ effective communication practices with internal customers (Supply Chain, Quality, Legal, Clinical, Customer Care).
• Review of Product complaints and liaise with the complaints team on open complaints. Assist in complaint investigation as necessary.
• Support role in validation activities
• Prepare status reports and metrics for assigned projects.
• Perform assigned work according to current good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
• Any other duties as assigned by your Manager.

What are we looking for?

• Life sciences degree (BSc or equivalent).
• 1-3 years of regulatory experience in the medical device or IVD industry.
• Experience assisting with the maintenance of EU technical files.
• Hardworking, self-motivated, and with attention to detail.
• Working knowledge of the USA and EU regulatory requirements and procedures.
• Familiarity with MS Office, or equivalent.
• Excellent written and oral communication skills, attention to detail, and the ability to handle multiple projects.
• Preparation of relevant technical, safety, and performance technical documents to support submissions, in collaboration with Technical/Clinical/Labelling experts.
• understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options.
• Compliance with SOPs, Change controls and regulatory best practices.

Benefits: 

Alongside a base salary of €45,000 - €50,000 we offer a range of benefits including: 

• Health insurance and an Employee Assistance Programme 
• Pension matching contribution
• Annual Compensation Reviews 
• LetsGetChecked has a flexible Annual Leave policy.
• Free monthly LetsGetChecked tests as we are not only focused on the well being of our patients but also the well being of our teams
• A referral bonus programme to reward you for helping us hire the best talent
• Internal Opportunities and Careers Clinics to help you progress your career within the company.  
• Bike to work scheme - and secure bike storage onsite. 
• Maternity, Paternity, Parental and Wedding leave.

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