Regulatory Device Scientist
il y a 4 jours
**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.
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