Head of Regulatory Affairs & Quality Assurance - 763

Head of Regulatory Affairs & Quality Assurance (RA/QA)

About the Company

We are a group of medical device companies developing cutting-edge multidisciplinary implantable cardiac devices. Our team brings together expertise from across medical, engineering, and technological disciplines to create innovative solutions that improve patient outcomes and advance cardiovascular care. Working at the intersection of medicine and technology, we are committed to pushing the boundaries of what is possible in cardiac treatment and transforming lives through our groundbreaking implantable products.

We are now looking for a passionate and experienced Head of Regulatory Affairs and Quality Assurance (RA/QA) to spearhead global compliance, regulatory strategy, and quality excellence as we advance toward commercialization.

Position Overview

The Head of RA/QA will be responsible for leading all regulatory affairs and quality assurance activities across the product lifecycle. This role requires a seasoned RA/QA leader with deep expertise in global medical device regulations, strong cross-functional collaboration skills, and the ability to build and scale robust regulatory and quality systems in a fast-paced startup environment.

Key Responsibilities

Regulatory Affairs

• Lead global regulatory strategy and execution for FDA, CE, and additional international markets.
• Plan, prepare, and manage regulatory submissions (e.g., IDE, 510(k), De Novo, PMA, technical documentation).
• Monitor evolving regulatory landscapes and proactively adapt strategies.;

Quality Assurance

• Develop, implement, and continuously improve the company’s Quality Management System (QMS).
• Ensure ongoing compliance with ISO 13485, FDA QSR (21 CFR 820), EU MDR, and other applicable standards.
• Lead internal and external audits, inspections, and certification activities.
• Oversee creation and maintenance of product Technical Files, DHFs and risk management documentation.

Cross-Functional Leadership

• Collaborate closely with R&D, Engineering and Clinical teams to guide product development from a regulatory and quality perspective.
• Influence design and development decisions to support efficient regulatory clearance and high-quality outcomes.
• Drive a company-wide culture of quality, compliance, and continuous improvement.

Requirements

• B.Sc - Mandatory
• M.Sc. — an advantage
• 7+ years of experience in RA/QA within the medical device industry
• Proven leadership experience in multidisciplinary environments (e.g., electronics, algorithms, software, mechanics, physics, materials)
• Strong expertise in EU MDR, FDA 21 CFR Part 820, ISO 13485, and global regulatory frameworks
• Demonstrated experience managing regulatory submissions and audits
• Excellent communication skills and ability to work effectively across teams
• High proficiency in English (written and spoken)