Global Regulatory Affairs Leader for MedTech NPI & FDA

elemed; Zürich; Híbrido; CHF 120.000 - 180.000; Jornada completa

Descripción de la vacante

elemed is seeking a Regulatory Affairs Manager to lead regulatory strategy for a new implantable medical device, guiding US and international regulatory submissions and building a robust submission plan. You will ensure QMS compliance, liaise with FDA, and collaborate with global teams to enable timely product launch.

The role focuses on bringing a class III implantable device to market, navigating CE marking, and shaping regulatory processes in a cutting-edge, patient-centric environment.

Formación

• Experience bringing a class III implantable medical device to market.
• Led CE marking.

Responsabilidades

• Guide regulatory strategy for the NPI of the product into the US and international markets.
• Build submission files and prepare for regulatory approvals.
• Decode global medical device regulations to support product development teams.
• Identify regulatory hurdles and develop mitigation strategies.
• Ensure compliance with the company’s QMS and applicable regulations.
• Serve as the company’s regulatory expert with FDA and regulatory inspectors/auditors.
• Collaborate with global regulatory teams to support the product.

Conocimientos

Regulatory strategy

FDA interactions

Global regulation

QMS compliance

CE marking

NPI support

Descripción del empleo

elemed is seeking a Regulatory Affairs Manager to lead regulatory strategy for a new implantable medical device, guiding US and international regulatory submissions and building a robust submission plan. You will ensure QMS compliance, liaise with FDA, and collaborate with global teams to enable timely product launch.

The role focuses on bringing a class III implantable device to market, navigating CE marking, and shaping regulatory processes in a cutting-edge, patient-centric environment.