Vice President Global QA/RA (m/w/d) 16.07.2026 Dr. Heimeier Executive Search Gmb

Vice President Global QA/RA (m/w/d)
Director, Quality Assurance & Regulatory Affairs, reporting directly to the CTO, responsible for global development and oversight of QA and RA functions in the medical device industry.

Responsibilities

Define and implement quality objectives, strategies and Quality Management Systems across all business units worldwide.

Plan and conduct audits, management reviews and regulatory activities to ensure compliance with international medical device regulations.

Lead the development and maintenance of quality documentation, approvals, risk management, post‑market surveillance and complaint handling.

Advise senior management on quality policy, regulatory requirements, investment planning and organizational development.

Manage cross‑functional collaboration, budgets and reporting of key performance indicators, risks and critical developments to the executive team.

Represent the company on behalf of customers, regulators, auditors and business partners.

Qualifications

Graduated in a technical discipline; additional qualifications as a quality manager or auditor preferred.

Minimum of several years of professional and managerial experience in Quality Assurance/Management and Regulatory Affairs within the medical device industry (MDR Class IIb or higher).

Strong knowledge of international regulatory requirements, modern QM methodologies and relevant IT systems.

Proven strategic thinking, excellent communication skills, international mindset and travel readiness.

Fluent in English, both written and spoken, and strong command of German.

Demonstrated leadership, adaptability, analytical thinking, customer orientation and the ability to develop people within a value‑based culture.

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