QA & Regulatory Compliance Specialist — Medical Devices

Empatica; Monza; On-site; EUR 40,000 - 66,000; 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 Quality Assurance/Regulatory Compliance professional to support design control, risk management, and verification/validation activities across development teams.

You will collaborate with Regulatory, Clinical Science, Marketing and Product Management to translate needs into compliant requirements and help maintain regulatory submissions and the Quality Management System.

Qualifications

• 3+ years of experience in QA, DQE, or similar roles in medical device companies.
• Familiarity with 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.
• Problem-solving.
• Autonomy.
• ISO 13485.
• ISO 14971.
• IEC 60601.

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

QA experience

DQE experience

Analytical skills

Problem-solving

Autonomy

Organizational skills

English proficiency

ISO 13485 knowledge

ISO 14971 knowledge

IEC 60601 knowledge

IEC 62304 knowledge

MDR 2017/745 knowledge

Analytical thinking

Job description

Empatica is seeking a Quality Assurance/Regulatory Compliance professional to support design control, risk management, and verification/validation activities across development teams.

You will collaborate with Regulatory, Clinical Science, Marketing and Product Management to translate needs into compliant requirements and help maintain regulatory submissions and the Quality Management System.