Do you want to be part of a new strategic focus area in Novo Nordisk? Are you passionate about developing digital products that make a difference for people with chronic diseases?
Are you passionate about compliance and turning quality into a business enabler? Can you translate complex quality-related challenges into simple solutions for stakeholders to understand and build a relation to become a trusted advisor? And most importantly - can you bring value in our journey of bringing innovative digital products to patients across the globe? Then we look forward to meeting you!
About the position
As a Lead SaMD & IT Compliance Advisor you will provide quality guidance for all the components that make up the eco-system of the digital solutions that we bring to the patients. This eco-system consists of front-end components that are in the hands of patients and a range of IoT devices, including connected medical devices, smartphones, mobile apps and websites.
To excel in this role, it is essential to possess robust experience working with compliance and regulated software, ideally underpinned by knowledge of software development practices and methodologies, and the ability to integrate compliance requirements into the software lifecycle, especially during development. Likewise, you will also benefit from having experience in implementing automated documentation processes to streamline compliance efforts and maintain accurate records.
You will work very closely with all members of your delivery team and other stakeholders in QA and Line of Business to ensure that your advice and guidance aligns with the goals and strategy of Novo Nordisk. In this job you will also play an important role in continuously shape and mature our process landscape for Health Software and Software as a Medical Device (SaMD) processes to fit the needs of Digital Health Solutions and across Novo Nordisk.

The position is based in Søborg (Denmark) and you will join an international team of more than 50 passionate employees in Digital Health Solutions. Here, you will become a member of one or more product delivery teams working across all phases of the software delivery lifecycle.

What are we looking for?
To be successful in the role, we believe you have:

Bachelor's degree in computer science, software engineering, information technology, or a related field.

3+ years of experience in compliance, regulatory affairs, or quality assurance within a regulated industry.

• It is a major advantage if you have experience working with SaMD and IEC 62304.

Strong communication skills with the ability to effectively convey complex compliance requirements to diverse audiences.

Demonstrated ability to work collaboratively in cross-functional teams and a strong commitment to upholding ethical standards.

Fluent oral and written English.

As a person you are known to be positive and diplomatic. You have a quality mindset that allows you to balance compliance best practices with other considerations from members of your delivery team, whether they are certain business objectives, technical feasibility concerns or patient safety risks. All in all, you can follow best practices, and explain complex technical concepts in both written and verbal form.

To succeed, it is crucial that you thrive with working in teams where you can inspire and motivate your stakeholders to take informed decisions. In addition, you must have strong work ethic and willingness to take responsibility to bring the best possible digital solutions to the market and you understand and value that you play an important part in making lives easier for people with diabetes and other chronic diseases. Since you will be working Globally you must expect some meetings to take place outside DK working hours and some travel activity.
About the department
Digital Health Solutions work in close collaboration with the Digital Health business units as well as external partners to bring innovative digital solutions to patients globally, living with diabetes and other chronic diseases.

Digital Health IT is responsible for the IT part of delivering Apps that are directly used by patients as well as the backend services and systems that support these.
The Apps are used for medical purposes and will likely be integrated with connected medical devices such as connected insulin injection pens and connected glucose monitoring devices. Known as “Software as a Medical Device”, these Apps are highly regulated and have strict quality requirements to ensure patient safety.

To succeed with this endeavor, Digital Health IT employs a total of 50+ fulltime internal and external colleagues with various backgrounds such as Project Managers, Compliance & Quality experts, Digital Solution Architects, System Managers/DevOps and we have established close relations with 3rd party suppliers and developers, that are accustomed to deliver highly innovative products in this regulated environment.

The department is growing and constantly evolving and is anchored within Digital Innovation in Global IT. As the name implies, we are continuously moving into new areas, where new and innovative competencies, solutions and perspectives are needed. The Department and colleagues are full of drive and are highly flexible and adaptive in an environment where changes, updates and releases are part of every day.

Join the Novo Nordisk family
Novo Nordisk is a global healthcare company headquartered in Denmark. For 100 years, we have been driving change to defeat diabetes and other serious chronic diseases. As a result, our treatments today benefit millions of people living with diabetes, obesity, and rare blood and endocrine diseases. We are proud of that.
We are proud of our people too, and we employ more than 57,000 bright and diverse minds in 80 offices worldwide. With us, your bright mind and commitment help us change lives for people worldwide. In exchange, we offer you a seat in a rewarding and purpose-driven culture where your professional and personal development is highly valued. That said, opportunities are many in Novo Nordisk.

Any questions?
For further information, please contact Henrik Christoffersen on +45 30758377.

Deadline
27 August 2024
This position is a part of the NN DK Employee Referral Bonus Programme. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.