Regulatory Affairs Manager EU

The following responsibilities are awaiting you:

• You prepare and submit applications for conformity assessments and clinical trials involving non-active implantable class III medical devices in the EU.
• You coordinate timely and accurate responses to questions from Notified Bodies and Competent Authorities.
• You compile, assess and update CE technical documentation and clinical trial application dossiers, including documentation provided by third parties.
• You advise cross-functional development teams on quality, analytical, preclinical, and clinical requirements to support the acceptance of regulatory submissions.
• You prepare and maintain product information in accordance with company core data, applicable legislation, and relevant guidelines.
• You manage the regulatory life cycle of CE-marked products, including renewals, change notifications, and annual updates.
• You assess regulatory implications of changes proposed by production sites, marketing teams, and other internal stakeholders.
• You coordinate regulatory projects and collaborate with external partners, including consultants, contract research organizations, and distribution partners.
• You develop regulatory strategies, contribute to cross-functional project teams, and serve as a contact person for regulatory requirements.
• You identify country-specific requirements and manage the submission and maintenance of documentation required in EU countries beyond the CE mark.
• You support additional regulatory activities and responsibilities as required.

• You hold a degree in natural sciences, pharmacy, biology, chemistry, engineering (medical devices / bioengineering), or a comparable discipline, ideally at master's or PhD level.
• You bring approximately 1-3 years of professional experience in EU regulatory affairs for medical devices.
• You have a sound understanding of the European regulatory landscape for medical devices.
• You demonstrate strong time management, problem-solving, communication, and digital skills.
• You work independently, remain resilient, and approach challenges with a structured and solution-oriented mindset.
• You collaborate effectively across functions and are able to coordinate projects and influence stakeholders without direct authority.
• You build constructive relationships with internal and external partners, including Notified Bodies and Competent Authorities.
• You communicate fluently and confidently in business English.