Device Responsible Person/Quality Engineer

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.

Inhalation Product Development in Gothenburg at AstraZeneca deliver the therapies of the future through scientific leadership in drug delivery, formulation, tox- and clinical supply of the Drug Product. We are part of AstraZeneca Operations, a truly world-class business unit which offers one of the most exciting, fast-paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

The role

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.

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:

* Author Design Controls documentation including DHF index and ERL/GSPR
* Lead Formal Technical and Design reviews
* Lead Formal Technical and Design reviews
* Perform supplier DHF reviews
* Write submission text for medical device section
* Support Quality with any device issues during clinical studies
* Provide experienced knowledge when it comes to device GXP ways of working
* Be a link between the QA, Regulatory Affairs, Supply Chain and PDT


About you

Are you one of us? We're self-starters, independent thinkers and results-oriented minds. People that grow with ownership -empowered to seek challenges and continuously innovate. But most of all we're a collective -diverse minds that move at pace and collaborate openly. All with a passion and seek to be better -fuelled by curiosity and backed up with countless opportunities to learn and grow every day. In addition to the personality traits above, to succeed in this role, we believe that you need to have good experience of working in medical devices' development within a Medical Device Quality or Regulatory department. We also trust that experience from working in the Pharmaceutical industry is helpful for this role.

Skills

* 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)

The seniority of the role can depend and be adjusted to what candidates that apply.

If you have any questions about this role, please contact Gunnar Haeffler, Team Leader, IPD-Got, at gunnar-haeffler@Astrazeneca.com