30 ott - Lodi
Empatica
Overview
In this role you help uphold Empatica's quality culture and regulatory compliance across development teams. You will support design control, risk management, and verification/validation activities to ensure products meet regulatory and company standards. You'll liaise with Regulatory, Clinical Science, Marketing, and Product Management to translate needs into compliant requirements and support submissions. Your work enables safe, high-quality devices while driving continuous improvement in processes and products.
Retribuzione / Benefits
- Health Insurance
- Employee stock options
- Flexible working hours
- Learning and development budget
- Wellhub gym access
- Free lunch every day
Responsabilità
- 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 products개`,
- 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
Requisiti fondamentali
- 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)
- analytical thinking
- problem-solving
- autonomy
- ISO 13485
- ISO 14971
- IEC 60601
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