Regulatory Affairs Manager EU

Progressive; Frankfurt; Vor Ort; EUR 52.000 - 70.000; Vollzeit

Zusammenfassung

Progressive seeks a Regulatory Affairs specialist to manage EU regulatory submissions for non-active implantable class III medical devices. You will coordinate with Notified Bodies and Competent Authorities, compile CE documentation, and guide cross-functional teams on regulatory needs.

Strong English communication and independence are essential. The role covers maintaining product information, lifecycle management of CE-marked products, and coordinating external partnerships to ensure compliant

Qualifikationen

• 1–3 years of EU regulatory affairs experience for medical devices.
• Strong understanding of the European regulatory landscape for medical devices.
• Fluent business English and effective cross-functional collaboration.

Aufgaben

• Prepare and submit conformity assessment and clinical trial applications for EU implantable class III devices.
• Coordinate timely responses to Notified Bodies and Competent Authorities.
• Compile, assess and update CE technical documentation and clinical trial dossiers.
• Advise cross-functional development teams on regulatory requirements for submissions.
• Prepare and maintain product information per legislation and guidelines.
• Manage regulatory lifecycle of CE-marked products including renewals and updates.
• Assess regulatory implications of changes from production sites and other internal stakeholders.
• Coordinate regulatory projects with external partners such as consultants and CROs.
• Develop regulatory strategies and act as a contact for regulatory requirements.
• Identify country-specific requirements and manage submissions beyond the CE mark.
• Support additional regulatory activities as required.

Kenntnisse

Regulatory affairs

Project coordination

Time management

Problem solving

Cross-functional collaboration

Business English

Ausbildung

Master's or PhD degree in natural sciences / related field

Jobbeschreibung

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.

What we expect from you:

• 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.