Regulatory Lead, Medical Devices (EU MDR & CE)

Eyedentity AB; Stockholms kommun; On-site; SEK 900,000 - 1,300,000; Full time

Benefits offered by this job

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Job summary

Eyedentity AB, based in Stockholm, seeks a Regulatory Lead to own regulatory work end-to-end and serve as PRRC. You will drive CE marking, MDR compliance, and the transition to a new eQMS, shaping how quality and regulatory work is done as the company grows.

The role is hands-on and requires a proactive, decision-driven mindset. You will write, review and drive regulatory activities, collaborating with product and clinical teams to ensure proper labelling, risk management and post-market

Qualifications

• University degree in engineering, life sciences, medicine, pharmacy or law.
• Hands-on experience with EU MDR and technical documentation within a QMS.
• Fluent English and a Swedish work permit.

Responsibilities

• Own regulatory strategy and plan for CE marking and MDR compliance.
• Drive technical documentation and be the main contact with Notified Body.
• Lead certification of new modules as the platform grows.
• Ensure consistency of intended purpose, claims, labelling and IFU.
• Provide regulatory input on product development, risk management, clinical evaluation, cybersecurity and post-market surveillance.
• Run and develop ISO 13485 QMS.
• Prepare for EU AI Act and groundwork for FDA submission.

Skills

Regulatory strategy

MDR compliance

Quality systems

Education

University degree in engineering, life sciences, medicine, pharmacy or law

Job description

Eyedentity AB, based in Stockholm, seeks a Regulatory Lead to own regulatory work end-to-end and serve as PRRC. You will drive CE marking, MDR compliance, and the transition to a new eQMS, shaping how quality and regulatory work is done as the company grows.

The role is hands-on and requires a proactive, decision-driven mindset. You will write, review and drive regulatory activities, collaborating with product and clinical teams to ensure proper labelling, risk management and post-market