QA Specialist – Medical Devices | ISO 13485 | Flexible Hours

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

Benefits offered by this job

Health Insurance

Employee stock options

Flexible working hours

Learning and development budget

Wellhub gym access

Free lunch every day

Job summary

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

You will liaise with Regulatory, Clinical Science, Marketing, and Product Management to translate needs into compliant requirements and support submissions, enabling safe, high-quality devices while driving continuous

Qualifications

• 3+ years of experience in QA, DQE, or similar roles in medical device companies.
• Knowledge of ISO 13485, 14971.
• Knowledge of IEC 60601, 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).

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.

Job description

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

You will liaise with Regulatory, Clinical Science, Marketing, and Product Management to translate needs into compliant requirements and support submissions, enabling safe, high-quality devices while driving continuous