Regulatory Affairs Specialist

at  LetsGetChecked

LetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked’s end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription fulfillment. Founded in 2015 and co-headquartered in Dublin and New York, LetsGetChecked empowers people to take control of their health and live longer, happier lives.

• Duties will be variable depending on the nature of the projects to be undertaken. These will mainly fall within the areas of Regulatory Affairs.
• To prepare and project manage high quality device registrations for approval by the US Food & Drug Administration and EU Competent Authorities.
• Liaise with the FDA on product classifications, De Novo and 510k applications
• Liaise with EU competent authorities, US FDA and Health Canada on device listing, establishment registrations, adverse event reporting and substantial changes.
• Be the Regulatory Affairs subject matter expert for Notified Body and other regulatory audits
• Work closely with the PrivaPath test laboratory and our other laboratory partners and test method qualifications/Clinical studies/LDTs to ensure regulatory requirements are continually met.
• Work closely with the Quality team in the areas of Vigilance, Post Market Surveillance and PSURs
• To monitor the progress of New Product Development, Renewal and Re-Authorisation submissions, respond to queries as they arise and ensure that regulatory requirements are met in a planned and timely manner to avoid delays in approval
• Commission studies with Contract Research Organisations and monitor the progress of the studies to ensure the target dates are maintained
• Contribute towards the development of the Regulatory Strategy
• Keep up to-date with US, EU and other global regulatory guidelines
• Build and maintain strong relationships with Regulatory Authorities, Consultants, CROs and internal departments
• Participate in Continuous Improvement Initiatives to further develop department functions.
• Maintain documentation such as general safety and performance requirements and technical files
• Review and approve labelling such as Instructions for Use
• Coordinate labelling translations
• Review and approve change requests for regulatory requirements in coordination with a cross functional team
• Act as responsible Regulatory Team member for assigned regulatory projects
• Actively participates and employs effective communication practices with internal customers (Supply Chain, Quality, Legal, Clinical, , Customer Care).
• Understand the Scope of Work, timelines and deliverables for a given project.
• Prepare status reports and metrics for assigned projects
• Perform assigned work according to current best good regulatory practice and in compliance with current legislation and regulatory guidelines at all times.
• Any other duties as assigned by your Manager