Senior Regulatory Affairs Manager, FDA & US Market (m/w/d)
Triga Consulting GmbH & Co KG · BE, DE
16 days agoImpress employers and recruiters.
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About the Role
Lead regulatory activities for the US market and serve as a key contact for the FDA for a specialist medical technology company. There is scope to progress into a Head of Regulatory Affairs position.
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.
Requirements
- 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.
Experience Level
- Experienced professional
Education Level
- Degree in a scientific or technical discipline, or equivalent experience
Benefits
- Structured onboarding and ongoing professional development.
- A collaborative team and modern, ergonomic working environment.
- Variable additional compensation, wellbeing support, and regular team activities.
About the Company
- An internationally active medical technology company developing products for clinical use.