Regulatory Expert - Medical Devices & MDR/CE Strategy

EBG MedAustron GmbH; Wiener Neustadt; Presencial; EUR 55.000 - 85.000; Jornada completa

Descripción de la vacante

MedAustron International GmbH in Austria seeks a Regulatory Expert (f/m/x) to drive regulatory activities for medical device development. You will shape regulatory strategy, ensure compliance with MDR, CE marking, and FDA processes, and support audits to advance patient-focused technologies.

You will collaborate with interdisciplinary teams, define design-control workflows, contribute to risk management per ISO 14971, and maintain technical documentation in line with ISO 13485 and IEC 62304,

Formación

• Completed technical or scientific degree in Medical Engineering, Mechanical Engineering, Electrical Engineering, Physics, or a related field.
• Strong understanding of product development processes and regulatory requirements in medical device development.
• Experience with ISO 13485 and IEC 62304 is advantageous.
• Excellent organizational and structured, solution-oriented working style.
• Strong communication skills and team-oriented mindset.
• Very good German and English language skills, both written and spoken.

Responsabilidades

• Contribute to compliant execution of regulatory activities for medical device development.
• Coordinate and execute usability engineering activities per IEC 62366.
• Contribute to risk management activities per ISO 14971.
• Define workflows and processes, especially design control.
• Prepare technical documentation.
• Implement regulatory strategies to obtain MDR CE marking and FDA 510(k); participate in audits.

Conocimientos

Regulatory affairs

Usability engineering

Risk management

Design control

Technical documentation

Regulatory strategy

Audits

ISO 14971

IEC 62366

ISO 13485

IEC 62304

German language

English language

Educación

Medical Engineering

Mechanical Engineering

Electrical Engineering

Physics

Descripción del empleo

MedAustron International GmbH in Austria seeks a Regulatory Expert (f/m/x) to drive regulatory activities for medical device development. You will shape regulatory strategy, ensure compliance with MDR, CE marking, and FDA processes, and support audits to advance patient-focused technologies.

You will collaborate with interdisciplinary teams, define design-control workflows, contribute to risk management per ISO 14971, and maintain technical documentation in line with ISO 13485 and IEC 62304,