Compliance Lead

**Your mission**:
We are looking for a Compliance Lead to establish, own, and oversee our regulatory and compliance frameworks. This role ensures our products and processes meet the highest standards required for medical devices, while partnering closely with our Head of Operations.
Reporting to the CEO, you will ensure regulatory, quality, and ethical integrity — ensuring that our precision oncology solutions are certifiable, auditable, and trusted.

**Job Key Responsibilities**

Regulatory & Quality Ownership
- Lead compliance strategy for MDR/IVDR, FDA, ISO 13485, ISO 14971, and SaMD frameworks.
- Maintain and update regulatory documentation (Technical Files, GSPR, CER, PMS/PMCF reports).
- Drive ISO 27001 certification and maintain alignment with GDPR, HIPAA, and the EU AI Act.

Audits & Certifications
- Act as the primary point of contact for regulators, notified bodies, and auditors.
- Prepare and lead certification, surveillance, and regulatory inspections.
- Coordinate internal audit readiness and ensure regulatory evidence is audit-proof.

Risk & Data Protection
- Own the company’s risk management system per ISO 14971.
- Lead privacy impact assessments (GDPR, HIPAA) and integrate requirements into engineering and clinical workflows.
- Collaborate with Ops to ensure vendor/supplier contracts meet compliance requirements.

Training & Awareness
- Define compliance training needs (QMS, regulatory, data protection).
- Educate teams on regulatory responsibilities and foster a culture of compliance.

Cross-Functional Collaboration
- Partner with the Head of Operations on Compliance sets requirements.
- Work with Product and Tech to embed compliance into design and development and ensure ethical and regulatory integrity in trials and deployments.

**Your profile**:

- 5+ years in regulatory, quality, or compliance roles in medical devices (SaMD/AI experience preferred).
- Strong expertise in ISO 13485, ISO 14971, ISO 27001, and regulatory submissions (CE/MDR, FDA 510(k)).
- Knowledge of GDPR, HIPAA, and emerging frameworks like the EU AI Act.
- Demonstrated experience preparing for and leading audits.
- Excellent communication skills.
- A mindset of integrity and rigor, balanced with pragmatism for a fast-moving startup.
- Ability to translate complex regulatory standards into clear, actionable requirements.
- Confidence in engaging directly with auditors, regulators, and partners.
- A collaborative style that empowers Ops, Product and Tech, while holding the line on compliance.

**Why us?**:

- The opportunity to make a real difference for cancer patients.
- Competitive salary, stock options, and extra benefits.
- A beautiful office near Alexanderplatz with an on-site gym, private showers, free drinks and snacks, rooftop bar, co-working space, and a quiet room for meditation or prayer.
- Competing at the global top-tier of cancer research together with the founders, who are renowned researchers in the field of AI for biomarker development from medical imaging.
- An extremely fast-paced and high-growth VC-funded start-up environment with key ownership from day 1.

**About us**:
StratifAI is an innovative Berlin-based precision oncology startup developing the next generation of AI-based cancer biomarkers. The founders have published over 100 articles in top-tier journals and founded StratifAI to translate these novel ideas into patient care.

Our products enable cancer patients to receive the right treatment at the right time - both for existing drugs on the market, and by supporting pharmaceutical companies in developing the drugs of tomorrow.