Regulatory Device Scientist

il y a 2 semaines

Anderlecht, Région de Bruxelles, Belgique UCB S.A. Temps plein

Make your mark for patients
We are looking for a Regulatory Devices Scientist to join us in our Global Regulatory Affairs team, based in our Anderlecht offices in Belgium

As a Regulatory Devices Scientist, you will have the following responsibilities:

  • Regulatory support of investigational and marketed medical device products including:
  • Health Authorities interaction
  • Regulatory assessments
  • Clinical Trials
  • Due Diligence
  • Feasibility Assessment
  • Technical review
  • Patient Risk Determinations
  • Establishes strong and effective relationships with global regulatory teams thereby ensuring activities are in line with global and regional business priorities
  • Supports and provides insights for the timely development and implementation of the global regulatory strategy and plan designed to meet the needs of the business and patients for assigned projects and initiatives.
  • Responsible for the authoring, review and approval of global/regional submission key documents (as applicable) and ensuring global alignment of key messages in line with objectives.
  • Supports the global CMC regulatory strategy for assigned projects/products and ensures it is consistent with the GRA teams, S&TS Teams and Patient Value Unit digital missions, goals and objectives.
Interested? For this position you'll need the following education, experience and skills:

  • Bachelor's degree
  • Experience working in a pharmaceutical environment, including direct experience with software as a medical device development.
  • Knowledge of global requirements for SaMD, wearable sensors investigational devices, clinical trial submission, product registration/variations, and license maintenance. Knowledge of cybersecurity, artificial intelligence in medical device software strongly desired. Global regulatory experience is a plus.
  • Knowledge of scientific foundation, sufficient to understand all aspects of regulatory issues in an authoritative way and discuss with technical experts. Knowledge of CFR part 11, Cybersecurity, Artificial Intelligence
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work for us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients.

We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work.

We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees or our planet.

Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.


Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

  • Medical Device Regulatory Scientist

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patients We are looking for a Medical Device Regulatory Scientist to join us in our Global Regulatory Affairs team, to be based in our Brussels (Belgium) offices The Medical Device Regulatory Scientist is responsible for regulatory activities for marketed and development medical devices and combinations products within the scope of...

  • Medical Device Regulatory Scientist

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Medical Device Regulatory Scientist to join us in our Global Regulatory Affairs team, to be based in our Brussels (Belgium) officesThe Medical Device Regulatory Scientist is responsible for regulatory activities for marketed and development medical devices and combinations products within the scope of the...

  • Regulatory Scientist

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB S.A. Temps plein

    Make your mark for patients.We're here because we want to build the future and transform patients' lives for the better. To achieve that, we need the brightest minds and biggest hearts. That's why our Talent Acquisition Team looks for passionate people inside and outside the company. Are you interested in an internal move that will allow you to explore how...

  • Regulatory Cmc Scientist

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Regulatory CMC Scientist - Small Molecules to join us in our Regulatory Affairs team, based in any of the following locations: Brussels (Belgium) or Slough (UK)About the roleDefine the strategy, planning and preparation (writing and review) of CMC documentation and sections for regulatory submissions from a...

  • Regulatory CMC Scientist

    il y a 4 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Regulatory CMC Scientist – Small Molecules to join us in our Regulatory Affairs team, based in any of the following locations: Brussels (Belgium) or Slough (UK) About the roleDefine the strategy, planning and preparation (writing and review) of CMC documentation and sections for regulatory submissions from a...

  • Regulatory CMC Scientist

    il y a 1 mois

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Regulatory CMC Scientist – Small Molecules to join us in our Regulatory Affairs team, based in any of the following locations: Brussels (Belgium) or Slough (UK) About the roleDefine the strategy, planning and preparation (writing and review) of CMC documentation and sections for regulatory submissions from a...

  • Regulatory Scientist

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB S.A. Temps plein

    Make your mark for patientsTo strengthen our Global Regulatory Affairs function, based in our Brussels offices we are looking for a talented individual to fill the position of Regulatory Scientist.As a Regulatory Scientist you will have the following responsibilities:Support the Global Regulatory Leader (GRL) for the delivery of timely approvals and product...

  • Regulatory Science Lead

    il y a 5 jours

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Regulatory Scientist – International Markets to join us in our Regulatory Affairs team, based in our headquarters in Brussels, Belgium. About the roleThe Regulatory Scientist International Markets is responsible for developing and implanting the international markets regulatory strategy in partnership with...

  • Safety Writing Scientist

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Safety Writing Scientist to join us in our Patient Safety & Medical Management team, based in any of our Brussels (Belgium), Slough (UK) or Raleigh (US) offices.About the roleScientific analysis and writing acumen to effectively articulate for benefit-risk assessments, safety risk management strategies, safety...

  • Head Global Labelling, Promotion

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patients We are looking for a Head of Global Labelling, Promotion & Advertisement to join us in our Global Regulatory Affairs team, based in either our Brussels, Belgium or Atlanta, Georgia (U.S.) offices. About the role The Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team (GRA-LT)...

  • Head of Global Safety Data Integration and Literature

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patients Position: Head, Global Safety Data Integration and Literature Make your mark for patients: We are seeking an innovative, strong communicator and influencing Head, Global Safety Data Integration and Literature to join our leadership team in the Product Pharmacovigilance & Device Safety team, ideally based in our Raleigh...

  • Head Global Labelling, Promotion

    il y a 1 mois

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Head of Global Labelling, Promotion & Advertisement to join us in our Global Regulatory Affairs team, based in either our Brussels, Belgium or Atlanta, Georgia (U.S.) offices. About the roleThe Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team (GRA-LT) and...

  • Head Global Labelling, Promotion

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB S.A. Temps plein

    Make your mark for patientsWe are looking for a Head of Global Labelling, Promotion & Advertisement to join us in our Global Regulatory Affairs team, based in either our Brussels, Belgium or Atlanta, Georgia (U.S.) offices.About the roleThe Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team (GRA-LT) and provides...

  • Head Global Labelling, Promotion

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Head of Global Labelling, Promotion & Advertisement to join us in our Global Regulatory Affairs team, based in either our Brussels, Belgium or Atlanta, Georgia (U.S.) offices. About the roleThe Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team (GRA-LT) and...

  • Head Global Labelling, Promotion

    il y a 4 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a Head of Global Labelling, Promotion & Advertisement to join us in our Global Regulatory Affairs team, based in either our Brussels, Belgium or Atlanta, Georgia (U.S.) offices. About the roleThe Head of Global Labelling & Promotion is a member of the Global Regulatory Affairs Leadership Team (GRA-LT) and...

  • Head of Global Safety Data Integration and

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsPosition: Head, Global Safety Data Integration and LiteratureMake your mark for patients:We are seeking an innovative, strong communicator and influencing Head, Global Safety Data Integration and Literature to join our leadership team in the Product Pharmacovigilance & Device Safety team, ideally based in our Raleigh (US), Monheim...

  • Pcor Lead

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB S.A. Temps plein

    Make your mark for patientsWe are looking for a Patient Centered Outcome Research (PCOR) lead who is expert in PRO studies with strong analytical and organizational skills to join us in our Global Patient Centered Outcome Research team team, based in our HQ in Brussels Belgium or in Slough, UKAbout the roleThe PCOR lead is responsible for evaluation of...

  • Eu Labelling

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB S.A. Temps plein

    Make your mark for patientsWe are looking for a European Labelling & Promotional Scientist to join us in our Regulatory team, based in our Brussels, Belgium officeAbout the roleProvides European Labelling & Promotional Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross...

  • Eu Labelling

    il y a 2 semaines

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsWe are looking for a European Labelling & Promotional Scientist to join us in our Regulatory team, based in our Brussels, Belgium officeAbout the roleProvides European Labelling & Promotional Regulatory expertise across a Therapeutic business unit. Delivers strategic and operational regulatory input and guidance to the cross...

  • Head of Global Safety Data Integration and Literature

    il y a 1 mois

    Anderlecht, Région de Bruxelles, Belgique UCB Temps plein

    Make your mark for patientsPosition: Head, Global Safety Data Integration and Literature Make your mark for patients:We are seeking an innovative, strong communicator and influencing Head, Global Safety Data Integration and Literature to join our leadership team in the Product Pharmacovigilance & Device Safety team, ideally based in our Raleigh (US), Monheim...