Regulatory Affairs Support Manager, North America
We are looking for an experienced Regulatory Affairs Support Manager to support North American regulatory activities from Germany. Acting as a key link between European and North American teams, you will assess product and process changes for their potential impact on FDA and Health Canada requirements.
This position does not include direct people-management responsibilities.
Your Responsibilities
- Support regulatory impact assessments for FDA and Health Canada submissions
- Review labelling, risk documentation, verification and validation data, design changes, new product developments and change-control activities
- Identify and elevate regulatory risks related to product changes and improvement initiatives
- Ensure North American regulatory requirements and timelines are considered within European workflows
- Maintain oversight of changes affecting North American regulatory documentation
- Coordinate information and communication between European and US cross-functional teams
- Support priority projects, including gap assessments, risk-file documentation and regulatory review activities
- Build strong partnerships across departments to support regulatory objectives
- Monitor changes in the regulatory landscape and advise internal teams on required actions
- Support positive collaboration with internal stakeholders and external regulatory authorities
Your Profile
- Bachelor’s degree in a technical or scientific discipline
- Professional experience in medical device regulatory affairs
- Strong knowledge of FDA regulations, Health Canada requirements, EU MDR and ISO 13485
- Fluent German and English
- Strong organisational and cross-functional collaboration skills
- Ability to manage several priorities and work with limited supervision
- Confident communicator who can work effectively with stakeholders at different organisational levels
- Good knowledge of Microsoft Office and ERP systems
What Makes You Successful
You are proactive, organised and comfortable working independently in an international environment. You can assess complex regulatory information, identify potential risks and communicate clear recommendations to cross-functional teams.
Interested?
If you have experience in medical device regulatory affairs and enjoy working between European and North American teams, we would be happy to hear from you.
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Regulatory Affairs Support Manager Arbeitgeber: Actalent
Actalent ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in Burnsville, Minnesota, eine dynamische und kollaborative Arbeitsumgebung bietet. Mit einem starken Fokus auf technische Exzellenz und kontinuierliche Verbesserung ermöglicht das Unternehmen seinen Mitarbeitern, an innovativen Projekten im Bereich der Luft- und Raumfahrttechnik zu arbeiten und sich beruflich weiterzuentwickeln. Die angebotenen Vorteile, einschließlich flexibler Arbeitszeiten, umfassender Gesundheitsleistungen und einer 401(k)-Rentenplanung, tragen dazu bei, dass Mitarbeiter sich geschätzt und unterstützt fühlen.
