Medical Devices Development Documentation Lead

vor 2 Wochen

Bulle, Schweiz UCB S.A. Vollzeit

**Make your mark for patients**

We are looking for a **Medical Devices Development Documentation lead** who is **accountable and has **e**xcellent **data management and **organizational skills** to join us in our **Pipeline Device and Delivery Systems team**, based either in **Braine l’Alleud** **(Belgium) **or in our offices in **Bulle (Switzerland)** or **Slough** (England)**.

**About the role**

This work will be performed in the context of cross-functional technical project and program

teams that ensure the design, development, industrialization, and life cycle management of

medical device and delivery systems to meet the needs of internal stakeholders and ultimately patients.

You will alternately contribute to the preparation of regulatory submissions with

business partners by coordinating the elaboration of the relevant documentation and manage the review and approval in the appropriate electronic document management system.

documentation and CMC sections of regulatory dossiers.

**Who you’ll work with**

You will work in a team environment, collaborating with various quality, regulatory, scientific, clinical and manufacturing experts.

This position reports to the Head of Devices and Delivery System Portfolio Management and industrial strategy.

**What you’ll do**
- You analyze and evaluate all available development, technical, commercial information and documentation and elaborate recommendation for the development team.
- You manage documentation within UCB’s data systems, evaluating the information, and the consistency of the reports.
- You author device and delivery systems development protocols, reports, risk assessment and templates.
- You verify data integrity for all relevant documentation.
- You interact with internal and external personnel on many aspects of project and technical documentation related matters
- You lead cross-functional and matrix teams, assess in project team the timelines and deliverables and coordinate and track the relevant documentation accordingly.
- You liaise with other departments or external partners to ensure documentation meets stakeholder’s needs (quality, regulatory, commercial manufacturing, etc ).

All these activities will be performed in compliance with Quality policies, standards, Quality Management System and with the regulatory requirements for each development phase of the products and devices.

**Interested? For this role we’re looking for the following education, experience and skills**
- You have a master degree in biology, chemistry, or another relevant field of study.
- You have a minimum of 3 years working in the pharmaceutical/biologics/medical industry.
- Operational GMP or quality experience would be a distinct advantage.
- You have a practical understanding of Good Manufacturing Practice and ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements.
- You can collaborate in the context of cross-functional internal and external project teams, in a cross cultural environment.
- You have excellent planning and organizational skills.
- You are experienced in technical writing in English.
- You can communicate technical data to non-specialist audiences from diverse backgrounds, coordinate cross-functional and matrix teams.
- You are accountable for decisions and actions taken.
- .You possess good interpersonal, verbal, and written communication skills and can confidently present information at interdepartmental meetings in English. You ensure free flow of information throughout the sphere of work.
- You can independently analyses data and information and assess the risks and actions to take within area of expertise, with an extensive quality experience.
- You are able to provide guidance for improvements, corrective and preventive actions related to processes.
- You are able to help others solve problems in a creative and practical way through development of solutions.

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.

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