QbD Group offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, Biotech and Medical Devices/IVD.

Our Regulatory Affairs division supports customers throughout the entire regulatory lifecycle of their products, whether they are traditional pharmaceutical products, generic medicines, vaccines, biologicals, biosimilars, medical devices, IVDs or Advanced Therapy Medicinal Products (ATMP). Our RA division has a strong international presence with over 100 colleagues in Belgium, the Netherlands, the UK, Spain, Poland and Austria. Our customer portfolio spans the entire globe (Asia, US, Europe, Africa).

We are looking for a Consultant RA IVD to join our team.

What do we expect from you as Consultant RA IVD?

1) Regulatory Consulting & Advisory Support, including but not limited to:

• Support regulatory consulting services to clients in the IVD sector.

• Contribute to the development of regional and global regulatory strategies, submission pathways and lifecycle planning under senior guidance.

• Support the identification and assessment of regulatory challenges across the product lifecycle and their regulatory, clinical performance and compliance impact.

• Monitor regulatory developments (e.g. IVDR, FDA) and support translation of changes into practical advice for clients and internal stakeholders.

• Support the preparation and delivery of client training sessions, workshops and presentations (on-site or remote) on regulatory and clinical topics.

• Make well-reasoned decisions within the agreed scope of responsibility and escalate complex or high-risk issues where appropriate.

2) Medical & Regulatory Writing, including but not limited to:

Contribute to the authoring, review and maintenance of regulatory and scientific documentation for IVDs in accordance with regulatory requirements, ensuring consistency, quality and submission readiness under senior oversight.

This includes, but is not limited to:

• Supporting the definition and documentation of 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, under guidance

• Authoring and reviewing analytical and clinical performance study reports, including final study reports, under guidance

• Contributing to the preparation, authoring and review of regulatory submission packages, including documents such as:

  • Clinical Performance Study Plans (CPSP)

  • Investigator’s Brochures (IB)

  • Informed Consent Forms (ICF)

  • Performance Evaluation Plans (PEP)

  • Scientific Validity Reports (SVR)

  • Performance Evaluation Reports (PER), where applicable

• Supporting regulatory submissions to Competent Authorities, Ethics Committees and Notified Bodies, including preparation of documentation 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 systematic literature reviews, data appraisal and evidence synthesis in support of scientific validity and clinical performance

• Applying templates, standards and SOPs consistently and supporting their development and continuous improvement

• Performing quality and regulatory compliance reviews of internally or externally authored documentation, escalating issues where appropriate.

3) Project Execution & Client Interaction, including but not limited to:

• Ensure correct and efficient execution of assigned tasks and responsibilities with minimal supervision and in an independent, yet collaborative manner, without compromising on quality.

• Organise and support project-related meetings (internal and external).

• Store client and project-related documentation in an organised, accurate and quality-minded manner in accordance with service-related procedures.

• Support the creation and maintenance of project plans using company-provided tools.

• Contribute to project execution by monitoring assigned deliverables, timelines and budget under senior oversight.

• Professionally liaise with colleagues and clients to communicate progress and support issue resolution.

• Support project management activities, including time tracking and cost monitoring, and escalate deviations where necessary.

4) Knowledge Sharing & Regulatory Intelligence, including but not limited to:

• Support and mentor more junior colleagues where applicable, contributing to a collaborative team environment.

• Monitor and track legislation within the IVD sector and support internal and external communication of regulatory requirements and changes.

• Support the collection, maintenance and sharing of regulatory information to achieve team and company objectives.

• Contribute to the drafting of subject-specific whitepapers, articles or blogposts.

• Participate in conferences, industry events and internal initiatives, representing the Qarad/QbD brand under guidance.

• Support internal regulatory initiatives, cross-functional workgroups and continuous improvement activities.

• Act as a point of contact for Regulatory Affairs-related questions within the agreed scope of expertise, escalating complex topics as needed.

5) Business Support, including but not limited to:

• Collaborate with internal Shared Services (e.g. Marketing, Finance, HR) where required.

• Support Sales and Business Development activities by contributing to client calls, visits or proposal preparation.

• Identify potential client needs or opportunities and communicate these to senior colleagues or the Sales team.

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 4 years relevant experience in regulatory affairs within the IVD, MD or biotech industry.

• You have experience with EU IVDR/MDR and/or FDA regulatory frameworks.

• Experience in medical and/or regulatory writing is a strong plus.

• Experience with literature reviews or evidence appraisal is a plus.

• You have strong written and verbal communication skills.

• You have strong scientific and regulatory writing skills.

• You have strong 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 company, you’re guaranteed to embark on a continuous journey of learning and development.

• Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

Our promise to you:

• As an ambitious and pioneering company, 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!