Senior Scientist - Device Design Controls

Hays Consultant opportunity as Device Responsible Person and Quality Engineer at AstraZeneca in Gothenburg

About AstraZeneca and the role
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. At AstraZeneca, we are proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

At AstraZeneca we turn ideas into life changing medicines and strive to continuously meet the unmet needs of patients worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.

Pharmaceutical Technology and Development (PT&D) is the organization that turns brilliant science into actual medicines that help millions of people. We work across the entire value chain, designing and delivering active ingredients, formulations and devices for new medicines and providing expert technical support to all AstraZeneca's commercial drug substances and products to ensure we successfully supply medicines to patients.

Inhalation Product Development (IPD) in sits within PT&D and is responsible for the development of inhalation products including combinations. Inhalation Product Development delivers the therapies of the future through scientific leadership in drug delivery, formulation and manufacturing the final drug product.
We are looking for a key person to join our multi-functional Product Development Team (PDT) for early phase clinical drug studies (Phase 1-2a). Take this opportunity to work in a role with overall device responsibility for clinical drug delivery system(s) and design control activities.

As part of the PDT this role taker will be device representative on the team and support by performing assessments on the selected drug delivery systems and the drug device combination/combination product. Your knowledge will be highly valued in regular project meetings as the Device specialist; project and clinical supply chain meetings.

What you'll do
Your role will be part Device Responsible Person and Quality Engineer which requires you to conduct the appropriate design controls activities and generate the DHF documentation as prioritized in the design and development.Responsibility to secure that the device and combination product work is delivered with the highest quality and compliant to applicable requirements from Health Authorities, Regulations and Standards where the specific studies will be conducted. Ensure that the right processes, procedures, and standard methodologies are executed and implemented.

Responsibilities will include, but not be limited to:

* Authoring Design Controls documentation including DHF index and ERL/GSPR
* Leading risk assessment activities and ensure that risks process is executed
* Leading Formal Technical and Design reviews
* Performing supplier DHF reviews
* Writing submission text for medical device section
* Supporting Quality with any device issues during clinical studies
* Providing experienced knowledge when it comes to device GXP ways of working
* Being a link between the QA, Regulatory Affairs, Supply Chain and PDT

Essential Requirements:

* Extensive understanding of process for development of Medical Devices and Combination Products; MDD/MDR, ISO 13485, FDA 21 CFR 4 and FDA 21 CFR 820
* Experience in establishing DHFs, Technical Files and Dossiers
* Good understanding technical standards; ISO, IEC FDA guidelines
* Good technical and regulatory writing skills* Proficient in English (speaking and writing)

To succeed in this role, we believe that you have experience of working with development of medical devices within a Medical Device Quality or Regulatory department.We also trust that experience from working in the Pharmaceutical industry is helpful for this role.

Why AstraZeneca
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.