Medical Devices QA Specialist – Regulatory Compliance

Empatica; Varese; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Health Insurance

Employee stock options

Flexible

Wellhub gym access

Free lunch every day

Job summary

Empatica is seeking a QA/Regulatory professional to uphold quality culture across development teams. You will support design control, risk management, and verification/validation to ensure products meet regulatory and company standards.

You will liaise with Regulatory, Clinical Science, Marketing and Product Management to translate needs into compliant requirements, enabling safe, high-quality devices and ongoing process improvement.

Qualifications

• 3+ years of QA, DQE, or similar roles in medical device companies.
• Knowledge of ISO 13485 and ISO 14971.
• Knowledge of IEC 60601 and IEC 62304.
• Knowledge of MDR 2017/745.
• Strong analytical and problem-solving skills.
• Autonomous with good organizational skills.
• Native English speaker or English-experienced (≥3 years).
• Analytical thinking and problem-solving highlighted in role.
• ISO 13485 and ISO 14971 familiarity.

Responsibilities

• Support maintenance and update of the Quality Management System.
• Provide quality reviews at design reviews, plans, risk management, and verification/validation activities.
• Assist with risk management activities and change management for new development and existing products.
• Help ensure design control documentation aligns product requirements with regulatory requirements.
• Support design transfer activities to ensure manufacturing quality compliance.
• Interface with Regulatory Affairs, Clinical Science, Marketing and Product Management to translate needs into compliant requirements.
• Draft and maintain regulatory documentation and procedures to meet Empatica and regulatory standards.
• Ensure production activities comply with internal procedures and international standards.
• Stay current on ISO/EN/FDA/MDR and related regulatory requirements and communicate implications to product teams.

Skills

Analytical thinking

Problem-solving

Autonomy

English proficiency

ISO 13485

ISO 14971

IEC 60601

IEC 62304

MDR 2017/745

Job description

Empatica is seeking a QA/Regulatory professional to uphold quality culture across development teams. You will support design control, risk management, and verification/validation to ensure products meet regulatory and company standards.

You will liaise with Regulatory, Clinical Science, Marketing and Product Management to translate needs into compliant requirements, enabling safe, high-quality devices and ongoing process improvement.