Laatste vacature-informatie van TRIUM Clinical Consulting NV voor de functie van Senior Consultant RA IVD. If the Senior Consultant RA IVD vacature in Antwerpen overeenkomt met jouw kwalificaties, stuur dan je meest recente sollicitatie of CV rechtstreeks via het bijgewerkte Jobkos vacatureportaal.
Houd er rekening mee dat solliciteren niet altijd eenvoudig is, aangezien kandidaten aan bepaalde eisen van het bedrijf moeten voldoen. We hopen dat de kans bij TRIUM Clinical Consulting NV voor de functie van Senior Consultant RA IVD hieronder matcht met jouw profiel.
What do we expect from you as Senior Consultant RA IVD?
Regulatory Consulting & Strategic Advisory:
Provide specialist regulatory consulting services directly to customers in the IVD sector.
Support clients in defining their regional and global regulatory strategies, submission pathways and lifecycle planning.
Anticipate regulatory challenges across the product lifecycle and assess their regulatory, clinical performance and compliance impact.
Monitor regulatory developments (e.g. IVDR, FDA) and translate changes into practical advice for clients and internal stakeholders.
Deliver client training sessions, workshops and presentations (on-site or remote) on regulatory and clinical topics.
Act autonomously in complex decision-making, supporting and defending regulatory Functies while escalating where appropriate.
Medical & Regulatory Writing:
Own, design, author and review regulatory and scientific documentation for IVDs in accordance with regulatory requirements, including full responsibility for regulatory content, consistency and submission readiness.
This includes, but is not limited to:
Defining the clinical evidence and performance evaluation strategy in support of regulatory conformity
Authoring and reviewing analytical and clinical performance study plans, including the Clinical Performance Study Plan (CPSP) and related protocols
Authoring and reviewing analytical and clinical performance study reports, including final study reports
Preparing, authoring, reviewing and coordinating the regulatory submission package, including documents such as CPSP, IB, ICF, PEP, SVR, PER (where applicable)
Supporting regulatory submissions to Competent Authorities, Ethics Committees and Notified Bodies, including preparation, coordination and responses to questions and deficiencies
Authoring or reviewing Instructions for Use (IFU), stability plans and reports, usability documentation and other regulatory deliverables impacting intended purpose, conformity, safety and performance
Performing and/or overseeing systematic literature reviews, data appraisal and evidence synthesis in support of scientific validity and clinical performance
Ensuring consistent application of templates, standards and SOPs, and contributing to their development and continuous improvement
Performing critical quality and regulatory compliance reviews of internally or externally authored documentation, retaining regulatory ownership of final deliverables
Project Management & Client Interaction:
Ensuring correct and efficient execution of assigned tasks and responsibilities, with minimal supervision and in an independent, yet collaborative manner, without compromising on quality.
Organising project related meetings (internal and external).
Storing client and project related documentation in an organised, accurate and quality-minded manner and in agreement with service-related procedures.
Creating detailed project plans using Bedrijf provided tools.
Efficient management of projects, defining the scope, understanding project risks, assigning team members to specific tasks, managing team members and monitoring project deliverables, timelines, and budget.
Professionally liaising with colleagues as well as the client to communicate and resolve potential issues.
Act as project manager for some projects and monitor progress, time spent versus budget and money spent versus budget. Approve project‑associated incoming invoices and ensure accuracy of all outgoing invoices.
Understands and has an impact on the budgets and rates of the team/client/QbD Group. Takes action when the budget is compromised. Escalates where necessary.
Lead Steerco meetings in an efficient, calm and constructive manner. Provide high-level presentations making difficult topics understandable to non-experts.
Supervise and guide more junior team members. Use expertise to support colleagues in their development. Match tasks to capabilities and provide constructive feedback. Act as a role model within the team.
Critically assess problems and explore multiple solution approaches. Conduct thorough analyses of complex issues, considering stakeholders. Escalate issues when needed.
Monitor and track legislation within the In Vitro Diagnostic medical devices industry and keep stakeholders informed of regulatory requirements and changes.
Support and assist with collection, maintenance and sharing of regulatory information to achieve team and Bedrijf objectives.
Write subject-specific whitepapers, articles, or blog posts.
Represent the Bedrijf at conferences and industry events, strengthening the Qarad/QbD brand.
Lead or provide input to internal regulatory affairs initiatives and cross-functional improvement activities.
Support members within the organisation with Regulatory Affairs questions and act as a subject matter expert.
Business Support:
Collaborate with internal Shared Services (e.g., Marketing, Finance, HR).
Collaborate with Sales and Business Development to expand RA services, supporting client calls or visits and interacting at multiple levels within a client organization.
Identify additional needs and new opportunities at the client and communicate these to the Sales team or across divisions.
Who are we looking for?
You have a Master’s degree or PhD in sciences, biomedical, medical or technological fields, or equivalent
You have minimum 8 years relevant experience in regulatory affairs within the IVD, MD or biotech industry.
You have proven experience with EU IVDR/MDR and FDA regulatory frameworks.
You have minimum 3 years experience in medical and/or regulatory writing.
You have minimum 2 years experience conducting systematic literature reviews.
You have excellent written and verbal communication skills.
You have strong stakeholder and expectation management skills.
You have excellent organizational skills and an analytical mindset.
You enjoy working in an international environment.
A true QbD’er can be recognized by the following qualities:
Resilient: Your strong and positive attitude helps you overcome any challenge
Hungry for knowledge: You are always open to learning
No non-sense mentality: you can be straightforward in a respectful way
Innovative: You are constantly looking for new and better solutions
(Not too) serious: your job is serious, but you don’t take yourself too serious.
What’s in it for you?
QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
As we’re a knowledge-based Bedrijf, you’re guaranteed to embark on a continuous journey of learning and development.
Be part of our global success story. As an award-winning Bedrijf we value everyone’s contribution and celebrate achievements together
Our promise to you:
As an ambitious and pioneering Bedrijf, we want to offer you the best possible environment to thrive within the life sciences.
Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
In short … We stand for? JPEG: Joy in Partnership, going for the Extra mile to Get things done!
Interested? Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!
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Job Info:
Bedrijf: TRIUM Clinical Consulting NV
Functie: Senior Consultant RA IVD
Werkplek: Antwerpen
Land: BE
Hoe te solliciteren:
Na het lezen en begrijpen van de criteria en minimale kwalificatie-eisen uitgelegd in de vacature-informatie Senior Consultant RA IVD at the office Antwerpen hierboven, voltooi onmiddellijk de sollicitatieformulieren zoals een sollicitatiebrief, CV, kopie van diploma, cijferlijst en andere bijlagen. Verstuur via de link 'Volgende Pagina' hieronder.
DEZE VACATURE IS VERLOPEN (Meer dan 30 dagen geleden).
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