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Associate Director, Device & Digital Safety

Posted date Mar. 18, 2025
Contract type Full time
Job ID R-222301
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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-222301 Date posted 03/18/2025

Location: Barcelona - Spain (3 days working from the office and 2 days working from home)

The Associate Director, Device & Digital Safety contributes to the Patient Safety Device, Digital and Diagnostic process area. The role sits in Global Patient Safety - Operations, Technology & Analytics and Chief Medical Office.

The Associate Director, Device & Digital Safety responsibilities includes but is not limited to providing support to the device, digital and diagnostic process area including implementation, communication, compliance, performance and inspection readiness.

Typical Accountabilities

  • Responsible for the lifecycle management assigned Patient Safety processes related to devices, digital and diagnostic

  • Demonstrate and contributes to a culture of “ownership” and efficient and effective holistic issue management that results in delivery of business need and includes top tier customer/partner engagement.

  • Support the oversight of medical device, digital health and in-vitro diagnostic regulations and local requirements that impact Patient Safety and/or require implementation

  • Serve as the delegate, where appropriate, for the Directors in Device & Digital Safety

  • Support the allocation of and contribution to digital, device and diagnostic consultation requests of Patient Safety

  • Partner with License Agreement & Contracts where medical devices, digital health or diagnostics are involved

  • Ensure “customer requirements” of those who utilise device, digital and diagnostic safety processes are understood, critically evaluated, prioritised and addressed within the area.

    • Work with Line Managers and Leadership to prioritise the needs and resources required to deliver these requirements, and provide feedback and clear rationale for any areas that will not be addressed.

  • Ensures that internal processes are fit for purpose and maximise the effectiveness of the outsourced delivery, working with relevant partners to improve processes.

  • Participate and provide expert operational and/or strategic input and guidance to enterprise projects and initiatives that deliver value to AstraZeneca's business and contribute to its bold ambition

  • Partner with system counterparts to ensure an integrated and holistic approach to processes and systems.

  • Actively seek and promote creative and innovative ideas to drive performance and bring new solutions to customers

  • Establish a global mind-set to systematically gather, consolidate & communicate regulatory authority and industry intelligence for the proactive continuous improvement of activities required to ensure license to operate and regulatory compliance

  • Accountable for being a great partner with supplier(s) providing all external services to the group as appropriate.

  • In partnership with peers, establish, champion and facilitate a top tier partnership relationship with the outsource provider.

    • Includes championing relationship with internal AZ partners and forging strong partnership with all customers/partners. Ensures that all internal and external relationships and interfaces are handled effectively.

Essential for the role

  • University degree or equivalent qualification in relevant scientific field, with relevant experience

    • two years, Post Graduate

    • three years, Bachelors

  • At least two year’s professional experience in patient safety, regulatory affairs or in quality management systems relating to combination products, medical devices and/or invitro diagnostics

  • Knowledge and understanding of global regulatory and pharmacovigilance requirements and an ability to balance this with industry standards to achieve business goals

  • Experience from design, development, implementation, maintenance, continuous improvement and ongoing customer support for business processes within the area of focus for role.

  • Experience from authoring standards documents (Standard Operating procedures)

  • Experience from development and provision of training through virtual meetings and other media

  • Experience in outsourcing and partnership with external vendors

  • Knowledge in project management skills, specifically leading teams

  • Demonstrated excellent skills in: written and verbal communication

  • Able to work with a 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 for the role

  • University degree or equivalent qualification in relevant scientific field, with at least five years relevant experience

  • PhD in scientific field

  • Knowledge of new and developing regulatory and pharmacovigilance expectations

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

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.