Medical Devices Regulatory & Quality System Engineer
Medical Devices Regulatory & Quality System Engineer
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Job Description
Our Company
Technogym inspires 70million daily users to train using our innovative & engaging solutions for fitness sport and health. By promoting the Healthness lifestyle of exercise a balanced diet and a positive mental approach AI Tracking & Longevity Technogym has rapidly grown into a success story of over 2800 employees at 16 branches expanding to more than 150 countries. It has been selected as Official Supplier to 10 editions of the Olympic Games - from Sydney 2000 to Milano Cortina 2026.
Suppose you are a team player with strong relationship skills and an international approach eager to invest your energy in building that case you have the right spirit to join Technogym because you have the IMBESTIO! You will naturally fit our culture if you work out and live a healthy lifestyle are proactive determined and are digitally savvy. Move with us for a better world!
Your Role
We are looking for a Medical Devices Regulatory & Quality System Engineerto join our HQ Quality Team at Technogym Village (Cesena Italy). In this role you will ensure device conformity and maintain technical documentation. You will manage post-market surveillance compliance with ISO standards and the CA/PA process while supporting the quality system related to MDR.
Your Impact
- Ensure device conformity and maintain technical documentation.
- Manage post-market surveillance vigilance and reporting obligations.
- Ensure compliance with ISO standards (ISO 13485 and ISO 9001).
- Manage and improve the CA/PA process.
- Maintain relations with certification bodies.
- Support the quality system related to MDR for new product development.
- Contribute to continuous improvement of the quality system and develop quality metrics.
- Coordinate internal audits and assist in external audits.
About You
Ideally you are passionate about working out enthusiastic and proactive while also down-to-earth and ethical.
What you should bring:
- Masters Degree in Engineering (Electronics Telecommunications Biomechanical Biomedical)
- Minimum of 5 years of experience in quality system management for medical devices
- Deep knowledge of ISO 9001-2015 and ISO 13485 standards
- Experience with MDR IMS processes and procedures management
- English proficiency (minimum level B2 CEFR)
- Strong problem-solving organizational and communication skills
- Proficiency in data analysis and statistical aptitude
Technogym is an Equal Opportunities Employer
Technogym is an equal opportunities employer. We welcome applications from all members of society irrespective of age sex sexual orientation race religion or belief.
Discover your potential with a career at Technogym where work means loving what you do taking on challenges learning from others sharing a vision and making it come true!
Employment Type
Full Time
