Regulatory Quality Engineer Medical Devices (M/F)

Job Description:

Quality & Regulatory Affairs Engineer - SaMD

CDI - Paris 8e - 60 to 70K€ package

The Role

As part of the development of digital medical devices, we are looking for a Quality & Regulatory Affairs Engineer specialized in SaMD to strengthen the QARA team.

You will work on highly operational topics related to the Quality Management System (QMS) and technical files for software medical devices, with strong interaction with the Tech and Product teams.

The objective: to guarantee the regulatory compliance of products while enabling teams to deliver quickly and efficiently.

Your Missions

You will notably be responsible for: Maintaining and evolving the QMS according to ISO 13485: procedures, indicators, quality reviews, quality assurance plans. Drafting, updating, and maintaining MDR technical files for medical device software.

• Managing documentation related to design, verification and validation, risks, IFU, and product evolutions.
• Performing and maintaining risk analyses according to ISO 14971.
• Reviewing evolutions and Product Change Requests in order to identify their quality, regulatory, and documentary impacts.
• Managing non-conformities, CAPA, and change controls.
• Participating in internal audits, external audits, and supplier management.
• Contributing to post-market surveillance activities and post-market analyses.
• Ensuring regulatory and normative monitoring and translating evolutions into internal practices.
• Supporting and raising awareness among Tech, Product, and Operations teams regarding quality and regulatory requirements.

A strong Tech dimension

You will regularly interact with technical teams.

It is therefore important to be able to understand a software development cycle, to exchange with Tech interlocutors, and to translate quality and regulatory requirements into concrete actions.

We are looking for someone who has already had real experience managing medical device software technical files, and who knows how to work cross-functionally with the teams developing the product.

The Profile Sought***Engineering, pharmacist, biomedical, quality, regulatory affairs, or equivalent Master's degree (Bac+5).

• 5 to 7 years of professional experience in Quality and/or Regulatory Affairs in medical devices.
• Significant experience in medical device software / SaMD, ideally 3 years or more.
• Mastery of ISO 13485, MDR 2017/745, and ISO 14971.
• Good knowledge of frameworks related to medical software, notably IEC 62304, IEC 82304, and IEC 62366.
• Concrete experience in managing technical files and the QMS.
• Good understanding of software development environments, SaaS, or e-health.
• Professional English.

Why join the team: A high-responsibility position on digital medical devices.

• Real proximity to Tech and Product teams.
• A growing HealthTech environment, with varied regulatory and product topics.
• A human-sized team where autonomy and initiative are valued.

Terms & Package***CDI cadre - forfait jours

• Location: Paris 8e
• 3 days on-site per week
• 7 weeks of leave/off per year
• Remuneration: 60-65K€ fixed + 5-6K€ complementary package
• Individual and collective performance bonus
• Health insurance covered at 72% - Meal vouchers of 9€, covered at 60% - Remote work allowance
• BSPCE granted after 4 months of seniority
• Possibility to invest in capital starting from 6 months of seniority
• Offices in a premium coworking space

If this opportunity interests you, please send your CV to the following address