Senior Regulatory Affairs Consultant (IVD) Our client is a growing precision medicine consulting firm with offices in the United States and Ireland.
They are seeking a Senior Regulatory Affairs Consultant to be a critical team member and first hire at the Ireland location.
This individual will support EU IVDR regulatory strategy and submissions for the firm's clients.
The primary roles and responsibilities include managing the development of EU IVDR regulatory submissions, development of overall EU IVDR regulatory strategy, and communicating with EU regulatory bodies on behalf of global clients.
This position will directly report to the CEO, who is based in the United States office.
Location:
Full-time located on-site in Galway, Ireland.
Key Responsibilities:
Carries out duties in compliance with established business policies and procedures Maintain audit-ready technical files for IVD products Submit IVD registrations in EU on behalf of clients Forward documents from the manufacturer, Authorised Representative, or Competent Authority as required Work closely with the US-based regulatory team to ensure a harmonized regulatory strategy is applied to global regulatory submissions Prepares for and assists with quality audits - internal and external, as required Monitor changes in EU IVD guidance/legislation Support EU IVDR Clinical Performance Evaluation studies and ensure appropriate monitoring, data integrity, and reporting throughout the study duration Submit submissions to EU National Competent Authorities and Notified Bodies on behalf of clients Support Companion Diagnostic EU regulatory strategies and work closely with US-based regulatory and technical teams on harmonized strategies Collaborate with Boudicca DX's US-based clinical, quality and regulatory consultants and client's cross-functional teams to initiate and conduct client performance studies that are scientifically sound and regulatory compliant Support clients with General Product Safety Regulatory (GSPR) compliance Support EU laboratory clients with health institution exemption (Article 5(5)) status compliance Ensure all IVD analytical and clinical validation studies are conducted in compliance with EU regulations, including IVDR, ISO 20916, and other relevant guidelines Educate/Train clients on EU IVDR Regulations Provide Postmarket Surveillance Support to monitor product safety & recall assistance Work with Regulatory Interns who provide support with regulatory research (predicate & precedents), regulatory analytics for intelligence, and scientific writing Coordinate meetings (by phone, video conference and face to face) with clients Complete any other duties as may be assigned by the Person Responsible for Regulatory Compliance (PRRC) or CEO Requirements: Technical/Scientific degree (BSc, MSc, or Ph.
D.) in biological/biomedical science 5 years of professional Regulatory Affairs experience focused on IVDs Professional writing expertise particularly with technical and regulatory documentation Strong expertise in managing technical files and navigating EU IVDR Experience with Companion Diagnostics (CDx) is desirable but not required Experience with Authorised Representative activities is desirable but not essential Strong attention to detail and the ability to work individually within a multi-disciplinary consulting team, as well as with global clients Demonstrated administrative, written and verbal communication, negotiation and influencing skills Organised, detail oriented, have a high level of confidentiality, and ability to work under pressure with changing priorities and deadlines Strongly proficient in MS Office Suite, Excel, Word, PowerPoint and interested in learning regulatory analytics tools and AI-based applications Excellent oral and written communication skills, organization and presentation skills Must be able to work independently with minimal supervision, as well as a team player, in a fast-paced environment Ability to be resourceful and proactive when issues arise Fluent in English (speaking and writing) Willingness and availability to travel on company business Able to attend EU regulatory and scientific conferences to represent company and support business expansion efforts In order to interact with sites in US time zone occasional out of hours working required This job description is not exhaustive and the job holder may be required to undertake additional duties from time to time.
Seniority level Mid-Senior level
Employment type Full-time
Job function Legal
Industries Staffing and Recruiting
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