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Associate Director, Digital & Devices Safety Scientist

Posted date Dec. 17, 2024
Contract type Full time
Job ID R-213914
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Why choose AstraZeneca Spain?

AstraZeneca Spain is a rising force in our global business. With headquarters in Madrid and our global hub in Barcelona, we’ve become an important international centre of excellence in the fight against critical disease. Boasting vibrant universities and business schools, the Barcelona ecosystem is a place where scientists can thrive. We attract a diverse workforce from across the globe, shining a beacon for innovation in a country that’s committed to clinical development.

We invite you to bring your talents to Barcelona where our respiratory medicine R&D and Global Marketing centre offers opportunities in R&D, IT, Commercial and HR. Or join us in Madrid and shape our growth in our BUs (Respiratory, Oncology & CVRM ), and a range of Corporate functions. Additionally, you can find sales roles throughout the country. Together, we’re contributing to a world-leading pipeline of therapeutics and delivering life-changing medicines to patients.

Who do we look for?

Calling all tech innovators, ownership takers, challenge seekers and proactive collaborators. At AstraZeneca Spain, breakthroughs born in the lab become transformative medicine for the world's most complex diseases. Alongside technical expertise, colleagues have the resilience, energy and collaborative mindset to change lanes, work with different teams and start projects from scratch.

Here, diverse minds and bold disruptors can meaningfully impact the future of healthcare using cutting-edge technology. Whether you join us in Madrid or Barcelona, you can make a tangible impact within a global biopharmaceutical company that invests in your future. Join a talented global team that's powering AstraZeneca to better serve patients every day.

Success Profile

Ready to make an impact in your career? If you're passionate, growth-orientated and a true team player, we'll help you succeed. Here are some of the skills and capabilities we look for.

Diverse collaborators

This is a speak-up culture that values collaboration. You’ll proactively bring your unique perspectives, experiences and skills to the table and seek the same from others. With our international team composition and the need for fast-paced collaboration, you’ll always be building new connections with colleagues.

Cutting-edge innovators

When you join us, you’ll be part of a team that embraces digital technology and data to transform the way we work and the work we do. Every day, you’ll help make history, empowered to ignite your creativity and build something enduring.

Resilient trailblazers

Here, the answers aren’t always available. So, you’ll need to bring a fearless, self-starter mindset to navigate uncharted territories. You’ll harness your ceaseless energy to discover and make the necessary connections with colleagues to shape the future and achieve maximum impact.

Agile movers

Seize ownership and excel with autonomy to enjoy the constant rush of ground-breaking discovery. Your ability to anticipate sudden shifts and adapt swiftly will prove critical as you make your mark in an environment that rewards initiative and resilience.

Responsibilities

Job ID R-213914 Date posted 12/17/2024

The AssociateDirector, Device & Digital Safety Scientist provides medical and scientific input to device and digital project/products. The role sits in Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.

The AssociateDirector, Device & Digital Safety Scientist responsibilities include but are not limited to providing support to the development of projects/products involving a device which will require contribution to documents such as hazard assessments and assessing safety data collected

Accountabilities

  • Provide ongoing safetyand clinical subject matter expertiseto device and digital projects/products.

  • Contribute to developing clinical device and/or digital documents, such as hazard assessments or complaint assessments, in collaboration with the Device & Digital Safety Physicians and Associate Directors. 

  • Review, analyse and interpret safety data obtained for device and digital development in collaboration with the Device & Digital Safety Physicians and/or Director Device & Digital Safety.

  • Support the Director, Device & Digital Safety who leads priority projects/products 

  • Responsible for device safety activities associated with combination products, supporting the Patient Safety Therapeutic Product teams with device regulatory requirements 

  • Perform duties as Medical Device Surveillance Leader defined projects/products.

  • Take accountability and lead resolution of safety issues and mediate cross-functional agreement related to assigned medical devices or digital assets.

  • Participate in cross-functional process improvement or other initiatives related to digital and devices on behalf of the Patient Safety organisation.

  • Contribute to the generation of Patient Safety’s position on innovative use of digital health solutions and medical devices in medicinal product development and post market activities

  • Deliver compliance with device constituent and medical device clinical/post market requirements

  • Support PS TA’s project/product teams with their implementation and useof digital and devices in association with their assigned AZ medicinal project/product

Essential Skills/Experience

  • Education & core experience 

  • Healthcare degree (e.g.Registered nurse, Respiratory therapist with at least three years of clinical experience post-registration, maintaining registration

or

  • Healthcare degree (e.g.Registered Nurse, Medical Doctor withat least one yearof clinical experience post-registration, maintainingregistration with two years of industry experience with medical device/device constituent experience 

or

  • University degree or equivalent qualification in a relevant scientific discipline, with at least eight years with medical device/device constituent experience and post-graduate training to your support ability to approve clinical documents

  • Knowledge and understanding of global medical device and digital health requirements and an ability to balance this with industry standards to achieve business goals

  • Excellent written and verbal English

  • Ability to manage multiple stakeholders

  • Extensive knowledge in project management skills, specifically leading teams

  • Demonstrated excellent skills in: written and verbal communication

  • Able to work with high degree of autonomy

  • Able to represent AstraZeneca externally where required

  • Key capabilities:

  • Understanding of governance processes

  • Process improvement (e.g. Lean methodology)

  • Collaboration/co-ordination

  • Ability to influence without authority

  • Open to multiple perspectives

  • Balanced perspective

  • Solution-focused

  • Experience with inspection activities

Desirable Skills/Experience

  • Experience of being nominated as Person Responsible for regulatory Compliance as defined in the EU Medical Device Regulation (Regulation (EU) 2017/745)

  • Leadership experience, of people or product development

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we follow the science with curiosity and courage. Our commitment to Oncology is driven by our ambition to eliminate cancer as a cause of death. With cutting-edge science fused with the latest technology, we aim for breakthroughs that transform medicine. Our collaborative research environment unites academia and industry, expediting research in some of the hardest-to-treat cancers. Join us to build a rewarding career dedicated to improving millions of lives.

Ready to make a difference? Apply now!

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.

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Reasons to Join

Thomas Mathisen

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Sales Representative Oslo, Norway

There are many things I enjoy when working at AstraZeneca, mainly the Speak up culture, the great colleagues that are in my teams, the great products that AstraZeneca provides to our patients and the challenging conversations I have around our medicines.

Christine Recchio

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Sales Representative California, United States

Working at AstraZeneca has impacted my life in such a positive way. I now have an improved work-life balance through creating my own schedule and time management, I feel a balance that I didn’t have before.

Stephanie Ling

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

Sales Representative Petaling Jaya, Malaysia

There are a lot of reasons why I enjoy working in AstraZeneca, my colleagues being one of them. My team members and the managers have provided a great deal of guidance in helping me to be more confident in my daily work.

What we offer

We're driven by our shared values of serving people, society and the planet. Our people make this possible, which is why we prioritise diversity, inclusivity, balance and sustainability. Discover what a career at AstraZeneca could mean for you.

An award-winning company

We're passionate about being a great place to work, and 84% of our employees would recommend us as an employer. We've been recognised as a Top Employer in Spain, an EFR Family Responsible Business, and we achieved third place in Forbes Spain's Top 50 Best Places to Work list.

Inclusive environment

Diversity and inclusion are embedded in everything we do, and our different views, experiences and strengths enrich our culture. There's no salary gap at AstraZeneca, and the number of female employees has increased by four per cent over the last three years. We've also made all positions fully accessible.

Work-life balance

Your wellbeing means a lot to us, and we're here to support you through all of life's ups and downs. That's why we offer an unpaid leave policy, annual leave, reduced-hours timetables and a host of benefits, including a retirement plan, long service award, and health and travel insurance.

Sustainability initiatives

We're committed to harnessing the power of science to become a more sustainable business. We've reduced our carbon footprint by over 9,000 kg of CO2 over the last two years, and we lead the European GoGreen Project, which aims to introduce environmentally friendly options in our fleet of corporate vehicles.

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.