Regulatory Affairs Specialist
LetsGetChecked is a leading at-home health testing company, with a platform that allows consumers to discover and access personalised health information conveniently, confidentially and accurately. We empower people to take an active role in their health to live longer, happier lives. LetsGetChecked was founded in 2015 and has corporate offices located in New York City and Dublin.
Regulatory Affairs Specialist
The Regulatory Affairs Specialist’s role involves working cross functionally with clinical, quality and engineering during the design process, test development, jurisdiction expansion and product lifecycle. This involves a broad range of activities including marketing authorization and submissions, vigilance and adverse event reporting and clinical evaluation in the In-Vitro Diagnostics/Medical Device environment.
The primary function of this role is to manage the Regulatory Affairs requirements in the global jurisdictions in which LetsGetChecked operates to ensure that they are managed in a smooth and efficient manner. The Quality and Compliance team based in Dublin are responsible for global regulation, managing pre- & post- market regulation for all product classifications and novel devices across EMEA, USA and Canada.
- 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.
- Act as responsible Regulatory Team member for assigned regulatory projects
- Actively participates and employs effective communication practices with internal customers (CMC, Supply Chain, Quality, Legal, Clinical, Pharmacovigilance, 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.
- Assist with complaints handling and product labelling/claims activities
- Review advertising/promotional materials for potential non-compliance
- Any other duties as assigned by your Manager
What we are looking for…..
- Life sciences degree (BSc or equivalent).
- 2-4 years regulatory experience
- Hardworking, self-motivated and with attention to detail
- Excellent working knowledge of the USA and EU regulatory requirements and procedures required.
- Familiarity with electronic submissions (eCTD) useful but not a requirement.
- Candidates must be familiar with MS Office, or equivalent, etc.
- Excellent written and oral communication skills required, attention to detail and ability to handle multi-faceted projects at the same time a distinct advantage.
- Preparation of relevant technical, safety and performance technical documents to support submissions, in collaboration with Technical/CMC/Clinical/Labelling experts
- Experience of emerging markets / international RoW markets and regulatory filings
- Quality control review of technical/ regulatory documents
- Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options
- Compliance with SOPs, Change controls and regulatory best practices
- Project management experience – an advantage
Learn more here
Job posted: 2021-03-25