What I Do – Current & Developing Capabilities
🔗 Practical connector work in development at the interface of MedTech, regulation, quality, and healthcare workflows.
Language / Sprache / Sprog
🛠️ How this page fits into my connector profile
This page describes where I can currently contribute and which capabilities I am deliberately developing. The focus is on supportive, structure‑oriented work in contexts where regulatory affairs, quality management, and operational practice meet – often in smaller organisations and early‑stage MedTech environments.
The aim is to show concrete types of work rather than titles: what I do today and what I am building towards.
📌 Current capabilities
Today, I can support in particular with the following types of work.
Structuring regulatory and quality questions
- organising scattered questions into clear groups and topics
- identifying missing information and dependencies
- creating an ordered list of clarification and decision points
Organising information into clear frameworks
- building overviews that connect requirements, processes, and roles
- visualising how different elements relate to each other
- providing a stable reference structure instead of isolated notes
Mapping processes, roles, and responsibilities
- describing how work is actually done across functions
- clarifying who is involved and where interfaces exist
- identifying unclear responsibilities and potential gaps
Clarifying uncertainty in early‑stage setups
- distinguishing between knowns, unknowns, and assumptions
- helping teams decide what to clarify first
- supporting realistic next steps instead of reactive changes
📚 Capabilities in systematic development
I am actively developing my capabilities in areas that strengthen my connector role.
MedTech regulatory affairs
- deepening understanding of regulatory frameworks for medical technology
- learning how specific requirements apply to products, processes, and documentation
- focusing on interpretation and translation into operational structures
Quality and risk management
- working with concepts oriented towards ISO 13485 and ISO 14971
- thinking in terms of quality systems, risk‑based decisions, and long‑term maintainability
- connecting quality expectations with everyday workflows and constraints
AI in healthcare
- assessing AI‑related approaches from a structural and process perspective
- considering risk, accountability, and integration into existing systems
- aiming to frame AI in healthcare within clear, documented workflows
Cross‑border workflow understanding (DE–DK–SE)
- observing how documentation, communication, and decision‑making differ between Germany, Denmark, and Sweden
- relating these differences to regulatory and quality expectations
- using this understanding to support structures that work across borders
🔎 Example situations where I add value
1. Early‑stage MedTech team with open regulatory questions
A small team has multiple regulatory and quality concerns but no overview. I help by:
- sorting questions into structured groups
- relating them to relevant topics or standards
- defining a sequence of clarification steps with clear ownership
2. Clarifying roles and responsibilities in a quality‑relevant process
A process involves several functions, but responsibilities are unclear. I support by:
- mapping the process and its variants
- defining roles, handovers, and key decision points
- identifying where documentation and quality evidence are needed
3. Translating a requirement into a practical workflow
A requirement is known at a high level, but its impact on daily work is vague. I work on:
- describing what needs to change in practice
- defining concrete steps and checkpoints
- aligning these with existing processes instead of creating unnecessary parallel paths
4. Cross‑border structure comparison along the DE–DK–SE axis
A setup spans more than one country. I help by:
- highlighting structural and cultural differences relevant for quality and regulation
- translating these into process implications
- suggesting realistic ways to align expectations and documentation
My contribution is to turn complex, cross‑functional topics into structured overviews and workable steps that support regulatory, quality, and operational work.
🎯 How these capabilities support my connector path
These capabilities support my development as a connector by:
- providing concrete ways to structure and stabilise work in early‑stage and evolving MedTech environments
- linking regulatory and quality expectations with operational practice
- integrating regional aspects, especially along the DE–DK–SE axis, into practical decision‑making
For anonymised examples of this type of work, see Portfolio – Selected Work (EN).