Senior Regulatory Affairs Manager, FDA & US Market (m/w/d)

Triga Consulting; Berlin; Presencial; EUR 90.000 - 130.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Wellbeing support

Team activities

Descripción de la vacante

Triga Consulting is seeking a Senior Regulatory Affairs Manager to shape US market access for a medical technology client in Berlin.

The role focuses on developing regulatory strategies, leading FDA interactions, and ensuring compliance with FDA and ISO 13485 standards. Opportunities exist to progress toward Head of Regulatory Affairs as the function grows.

Formación

• Regulatory affairs experience in the medical device industry.
• Experience communicating with the FDA.
• Familiarity with FDA premarket pathways and ISO 13485.
• Fluent written and spoken German (C1) and English.

Responsabilidades

• Develop US regulatory strategies and prepare FDA submissions for market access.
• Lead FDA interactions, including pre-submission discussions and responses to agency questions.
• Coordinate regulatory input across research, development, quality, and commercial teams.
• Assess regulatory impacts of product/process changes on existing authorizations.
• Maintain compliance with FDA quality requirements and align with ISO 13485.

Conocimientos

Regulatory affairs

FDA communications

ISO 13485

German & English fluency

Educación

Degree in a scientific/technical discipline

Descripción del empleo

Berlin: Senior Regulatory Affairs Manager, FDA & US Market (m/w/d) | Medizintechnik

Shape the US regulatory strategy for a specialist medical technology company

Our client is an internationally active medical technology company developing products for clinical use.
To strengthen its Regulatory Affairs function, the company is seeking an experienced professional to lead regulatory activities for the US market and serve as a key contact for the FDA.
As the function develops, there is scope to progress into a Head of Regulatory Affairs position.

Senior Regulatory Affairs Manager, FDA & US Market (m/w/d)
Location: Berlin

Your responsibilities

• Develop US regulatory strategies and prepare FDA submissions for market access.
• Lead FDA interactions, including pre-submission discussions and responses to agency questions.
• Coordinate regulatory input across research, development, quality, and commercial teams.
• Assess regulatory impacts of product and process changes on existing authorizations.
• Maintain compliance with FDA quality requirements and align processes with ISO 13485.
• Monitor FDA guidance and translate regulatory changes into practical actions.
• Prepare for, support, and follow up on FDA inspections.
• Manage establishment registration, device listings, and product records in US databases.

Your background

• A degree in a scientific or technical discipline, or equivalent experience.
• Relevant Regulatory Affairs experience in the medical device industry.
• Demonstrated experience communicating directly with the FDA.
• Practical knowledge of FDA premarket notification pathways and quality requirements.
• Confidence working with ISO 13485 and US regulatory requirements.
• Fluent written and spoken German (C1) and English.
• A structured, analytical, independent, and precise approach to work.
• Strong communication and collaboration skills.

What the role offers

• A responsible position with scope to shape US market access.
• Structured onboarding and ongoing professional development.
• A collaborative team and modern, ergonomic working environment.
• Variable additional compensation, wellbeing support, and regular team activities.
• The opportunity to grow into a future Head of Regulatory Affairs role.