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 Senior Consultant RA IVD to join our team.

What do we expect from you as Senior Consultant RA IVD?

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

• 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 positions while escalating where appropriate.

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

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:

  • 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, 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

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

• 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).

• Store 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 company 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 as such monitor progress, time spent versus budget as well as money spent versus budget. Approve project associated incoming invoices associated to costs incurred 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. Give high-level presentations making difficult topics understandable to non-experts.

4) Coaching, Knowledge Sharing & Regulatory Intelligence, this includes but is not limited to:

• Supervise and guide (coach) more junior team members. Uses their expertise and shows appreciation to encourage and inspire colleagues in their general and/or technical development. Offers support to colleagues to complete their tasks and achieve results. Match tasks to the capabilities of each colleague. Gives honest and constructive feedback and makes others feel involved. Acts as a role model within the team.

• In case of problems, is critical of proposed solutions and assesses them as part of the bigger picture. Looks outside the box for multiple solution approaches and/or supports others in doing so. Conducts thorough analyses of complex issues, taking into account the contribution/weighting of the various stakeholders (both the client and QbD Group). Is pragmatic. Ensures that the solutions and action plan come to fruition. Escalates issues when needed.

• Monitoring and tracking of the legislation within the In Vitro Diagnostic medical devices industry with the intent to keep stakeholders (internal and external) informed of regulatory requirements and changes and to take the necessary actions if these changes affect any of the company processes and/or services.

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

• Writing of subject specific whitepapers, articles, or blogposts.

• Represent the company at conferences, industry events and external meetings, strengthening the Qarad/QbD brand.

• Leading or providing input to internal corporate regulatory affairs initiatives, cross-functional workgroups and continuous improvement activities.

• Supporting members within the organisation with Regulatory Affairs specific questions and acting as a subject matter expert and point of reference.

5) Business Support, including but not limited to:

• Collaborating when required with internal Shared Services (e.g., Marketing, Finance, HR etc.).

• Collaborating with Sales and Business Development for the further expansion of our RA services by supporting with client calls or visits in which you show commercial flair and interact professionally at multiple levels within a client organization.

• Identifying additional needs of and new opportunities at the client and adequately communicating these to the Sales team or across the 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 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!