Government Affairs Consultant

Role purpose

The Government Affairs consultant will support delivery focused on institutional adoption of nanopore sequencing across clinical validation, data governance, quality standards and reimbursement pathways.

The role will help bridge central government, statutory self-governance, Länder-

level institutions, university medicine, patient/ecosystem stakeholders and

industry bodies. It should strengthen the genomics ecosystem, particularly around § 64e SGB V /

Modellvorhaben Genomsequenzierung, genomDE, BfArM-led data-platform

structures, the Health Data Use Act (GDNG), FDZ Gesundheit/Health Data Lab,

EHDS implementation, and future routine-care reimbursement routes.

Strategic objectives

• Germany's genomic medicine, health-data and preparedness agenda - not

only as a research-tool provider or sequencing vendor.

• Build a clear, compliant policy narrative for multi-omic, real-time nanopore

sequencing in rare disease, oncology and pathogen genomics.

• Identify the policy, evidence, reimbursement, interoperability and

institutional barriers that could affect clinical scale in Germany.

• Create trusted and transparent engagement with priority public institutions,

self-governance bodies, clinical networks, patient organisations and industry

associations.

Key responsibilities

• Strategy and positioning: Develop the Germany government affairs plan and

policy narrative for nanopore sequencing in genomic medicine, health-data

infrastructure, reimbursement and preparedness.

• Stakeholder engagement: Build compliant relationships with priority federal,

self-governance, Länder, trade-association, clinical-network and patient

stakeholders, including BfArM/genomDE/MV GenomSeq, G-BA/IQWiG and

VDGH.

• Policy intelligence: Monitor § 64e SGB V, genomDE, GDNG/FDZ Gesundheit,

EHDS, IVDR, ePA and reimbursement developments; summarise

implications, risks and opportunities.

• Evidence and access: Support Market Access, Medical/Clinical Affairs,

Regulatory and technical teams on evidence gaps, validation requirements

and policy barriers in rare disease, oncology and pathogen genomics.

• External representation: Support agreed policy forums, association work,

stakeholder briefs, meeting readouts, roundtables, consultation inputs and

position papers, in conjunction with central Government Affairs team.

• Compliance and reporting: Maintain stakeholder maps, engagement

trackers and monthly intelligence notes; ensure activities follow

German transparency requirements and Legal/Compliance review.

Profile

Essential

• Native or fluent German speaker with strong English
• Significant experience in German health policy/government affairs
• Strong understanding of Germany's healthcare system, including

federal/Länder structure and key decision-making bodies

• Proven ability to credibly engage with public institutions, clinicians, and scientific stakeholders

Desirable

• Experience in genomics, diagnostics, or precision medicine
• Familiarity with key frameworks (e.g. §64e SGB V, G-BA/IQWiG processes,

genomDE, EHDS)

• Existing network across government, policy and to some extent university hospitals, research institutes, or relevant agencies
• Understanding of the wider EU policy landscape and the role of Brussels

Why this role matters

Germany is an institution-led market where clinical adoption depends on

validation, governance, and reimbursement systems rather than commercial

access alone.