Vanderbilt School of Medicine PhD Student/Postdoctoral Fellow ASPIRE Internship: Regulatory Science (Remote)
Vanderbilt School of Medicine PhD Student/Postdoctoral Fellow ASPIRE Internship: Medical Writing (Remote)
Boudicca DX, LLC Translational Science Affiliate Consultants (Hourly Pay & Remote)
- At least two years of translational science/clinical biomarker development experience at a Biotech/Pharma company
- Knowledgable in Companion Diagnostics (CDx)/Biomarker Drug Development Tools
- Strong attention to detail and analytical skills
- Ability to work independently and remotely as a consultant
- PhD in a relevant field
- Preferred: prior consulting experience
- Contract role (1099 employee)
If you are interested in supporting the Boudicca DX consulting team on translational science/clinical biomarker development projects, reach out directly to Carlos Murrieta: carlos@boudiccadx.com
Senior Regulatory Affairs Consultant (IVD) Located in Galway, Ireland
Senior Regulatory Affairs Consultant (IVD)
Boudicca DX is a growing precision medicine consulting firm with offices in the United States and Ireland. Boudicca DX’s clients include Pharmaceutical Companies, In Vitro Diagnostics (IVD) manufacturers and Clinical Laboratories. Boudicca DX is 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.
Salary:
€ Not Disclosed
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 Safety and Performance Requirements (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
- Manage secure client documentation storage archives
- 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
Benefits:
- Competitive salary
- 20 days of annual leave and paid public holidays
- A minimum of one conference a year to support continuing regulatory education
- Personal retirement savings account
- Ground floor opportunity with the team; shape the direction of this rapidly growing company
This job description is not exhaustive and the job holder may be required to undertake additional duties from time to time.
Reach out to carlos@boudiccadx.com for more information.