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

Triga-Consulting-Gmbh-; Berlin; On-site; EUR 90,000 - 150,000; Full time

Benefits offered by this job

Wellbeing support

Team activities

Structured onboarding and development

Growth into Head of Regulatory Affairs

Job summary

Triga Consulting GmbH is seeking an experienced Regulatory Affairs professional to lead US market regulatory activities for a medical technology client. You will shape US strategy and act as the primary liaison with the FDA, driving submissions and compliance.

As the function evolves there is clear potential to progress into Head of Regulatory Affairs. You will collaborate with R&D, QA, and commercial teams to ensure timely market access and ongoing compliance with FDA and ISO 13485 requirements.

Qualifications

• Degree in a scientific or technical discipline or equivalent experience.
• Regulatory Affairs experience in the medical device industry.
• Direct experience communicating with the FDA.
• Practical knowledge of FDA premarket pathways and quality requirements.
• Fluent written and spoken German (C1) and English.
• Structured, analytical, independent and precise approach.
• Strong communication and collaboration skills.

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 R&D, quality, and commercial teams.
• Assess regulatory impacts of product and process changes on existing authorizations.
• Maintain compliance with FDA quality requirements and ISO 13485 alignment.
• Monitor FDA guidance and translate regulatory changes into actionable steps.
• Prepare for, support, and follow up on FDA inspections.
• Manage establishment registration, device listings, and product records in US databases.

Skills

Regulatory strategy

FDA communications

ISO 13485

German (C1) and English

Analytical and precise

Structured approach

Cross-functional collaboration

Education

Science/engineering degree

Job description

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.

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.