Job Description

The Regulatory Affairs Specialist will work under the responsibility of the Quality and Regulatory Affairs Manager for the Regulatory Affairs activities including device registration in the target markets (Europe, USA and China).

Our ideal candidate will have previous experience in the medical device industry.

The role will evolve with the growth of the company and the various projects to come.

Your missions will be the following:

• Ensure compliance with regulatory requirements: 21 CFR part 820, ISO 13485, MDR 2017/745 and ensure compliance of products and services according to territories.
• Carry out regulatory registrations for the company’s products, services, and activities.
• Draft and complete the registration files for medical devices for the target markets USA-510k/Europe-CE/China (registration applications, modifications, etc…).
• Ensure regulatory activities related to product development and/or product modification in the context of medical device registrations.
• Provide support on regulatory information required by internal and external customers.
• Carry out regulatory monitoring.
• Analyse and communicate within the company the regulatory requirements concerning the medical devices for which they are responsible.
• Create, implement, and monitor appropriate quality procedures necessary for local business and marketing of products and services.

Profile

• You have an engineering degree or Master II in the field of regulatory affairs or Master II in the Medical/Scientific field.
• You have a good knowledge of the quality and regulatory environment: ISO13485, 21CFR820, MDD93/42, MDR 17/745, 510k, IEC60601 and collateral.
• You have good normative knowledge of active medical devices and software.
• You are rigorous, organised and have a synthetic and analytical mind.
• You have the ability to communicate effectively and establish relationships with internal and external contacts.
• You have a strong team spirit.
• You have a good level of English (written/oral).

Working at Quantum Surgical means

• Joining a talented, dynamic and multicultural team whilst being part of the technological and human adventure of a company in full evolution.
• Sharing our culture of innovation, team spirit and result-oriented
• Taking up technical challenges
• Benefiting from a competitive compensation (fixed salary + variable, BSPCE, meal-vouchers Swile)