Senior SaMD Specialist

Join the Digital Health team at Coloplast! 

As part of the Digital, Data and IT (DDIT) department, the Digital Health team works closely with colleagues across the organisation to deliver Medical Device Software (MDSW). Our current focus is the Heylo product; the world’s first leakage detection notification system. 

We are looking for a Senior SaMD Specialist to join our team to ensure our MDSW processes and procedures are efficiently managed, aligned with regulatory requirements, and continuously improved to meet the highest quality standards. 

As Senior SaMD Specialist, you will own the Design- and Change Control related processes, procedures, and instructions for the software teams delivering Coloplast’s Medical Device Software (MDSW) products. Specifically, this means driving the adoption of standards such as IEC 62304, MDR, and Coloplast’s own QMS across the product lifecycle; from requirements gathering through design, development, verification, and release. 

This key role will identify optimisation opportunities to ensure our processes and tools are efficient, our teams are thoroughly trained, and our ways of working continuously improved to meet the highest quality standards. Morover your main responsibilities will be:

Process Ownership: Serve as the owner of Medical Device Software processes and procedures within Digital Data and IT (DDIT), providing expert advice and support to software teams. Ensure these processes adhere to global quality standards, regulatory requirements (e.g. IEC 62304, FDA, MDR), and corporate policies, and ensure a framework to proactively monitor and react to regulatory changes. 
 

Continuous Improvement and Standardisation: Collaborate with teams to support and evolve our MDSW processes and tooling, to drive efficiency gains, risk reduction, and overall quality improvement. Communicate process changes and updates effectively across the organisation. 
 

Documentation: Own the preparation and maintenance of key documents, including SOPs such as the Medical Device Software Lifecycle. 
 

Training and Development: Develop and deliver training materials to ensure cross-functional software development teams are able to execute MDSW processes effectively. Foster a culture of continuous improvement and continuous compliance. 
 

Implementing Agile Delivery of Medical Device Software: Optimise processes and ways of working in line with Agile MDSW delivery, for example by utilising principles from AAMI TIR45 
 

Collaborate across functions: Work hand-in-hand with R&D, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing etc. to enable teams to successfully deliver high quality, compliant Medical Device Software. 
 

Access Control & System Management: Oversee system access for key software, ensuring that only qualified personnel have access, and that necessary training and documentation are in place. 
 

Requirements Engineering: Be able to mentor and guide junior colleagues working with subsystem requirements refactoring projects, based on best practises such as INCOSE/EARS. 

You will bring:

• A minimum of 10 years’ experience in the medical device software industry, with comprehensive knowledge of Design and Change Control processes, and standards such as IEC 62304, MDR. 
• Proven experience with optimising digital delivery processes within regulatory frameworks/standards and Quality Management Systems, and you should have successfully trained others on how to adopt these ways of working. 
• At least 5 years of experience working with digital products (web/app or standalone medical device with software), ideally with a strong understanding of the Agile mindset. 
• Proven experience in managing stakeholders, and driving effective cross-functional collaboration. 
• Some experience with owning and maintaining internal procedures and SOPs, and have been through audits and inspections. 
• Ideally, experience working as a System/Requirements Engineer, and can help continuously improve our subsystem requirements. 
• Fluency in both spoken and written English. 

Interested? 

If you are passionate about improving how digital teams deliver Medical Device Software, we encourage you to apply. If you would like more information, please reach out to Megan Dyton, Head of Digital Health, at dkmegdyt@coloplast.com. 

We will take candidates into the recruitment process continuously. The position will remain open until a suitable candidate is found. 

Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward – we explore, learn and look for new ways of doing things.

Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because – and not despite – of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.

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