Job description

For our client, we are looking for Head of Regulatory Affairs and Design Assurance

Be part of an innovative team bringing new technologies to the treatment of critical health conditions.

Key Responsibilities:

Prepare and maintain technical documentation in compliance with industry standards and regulations (e.g., ISO 13485, ISO 9001).
Manage and develop the company’s Quality Management System (QMS).
Support conformity assessments of products with applicable standards.
Lead registration processes in global markets, including the EU (MDR) and the US (FDA).
Collaborate with accredited laboratories, notified bodies, and internal departments.
Plan and execute internal and external audits.
Identify non-conformities and oversee corrective and preventive actions (CAPA).

Requirements:

Higher education (preferably in pharmacy, biotechnology, biomedical engineering, medicine, physics, chemistry, or related fields).
Minimum of 5 years of professional experience in product development or regulatory affairs.
Strong knowledge of ISO 13485 and regulatory standards.
Proficient in English (spoken and written).
Strong teamwork skills with the ability to work independently.

Nice to Have:

What We Offer:

Active involvement in the design and development of innovative, life-changing technologies.
An ambitious role in an international environment with a focus on global markets.
Opportunities to attend leading international conferences and industry events.
Competitive salary and performance-based incentive programs.
Flexible employment contract or alternative forms of cooperation, based on your preferences.
Professional development opportunities through training and certifications.
Supportive, team-oriented work culture in a dynamic and innovative company.

Take the Next Step in Your Career – Join Us and Shape the Future of Healthcare!

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Head of Regulatory Affairs and Design Assurance