Team Lead Regulatory Affairs – Medical Devices (m/f/d)

ZABEL; Berlin; Híbrido; EUR 90.000 - 140.000; Tempo integral

Resumo da vaga

Zabel is seeking an experienced Team Lead Regulatory Affairs (m/f/d) in Berlin. You will lead a skilled RA team, oversee international submissions and market access, and work closely with Quality, Medical Affairs, R&D and other functions to ensure regulatory compliance.

The role offers a strategic stance beyond execution, shaping regulatory processes, improving QMS practices, and driving cross-functional alignment in a global MedTech environment.

Qualificações

• University degree in natural sciences, engineering, medicine or equivalent.
• Several years of regulatory affairs experience in the medical device industry.
• Strong knowledge of international market access and conformity assessment.
• Experience with notified bodies and regulatory authorities.
• Solid understanding of QMS and audit processes.
• Leadership experience or readiness to manage people.
• Structured, proactive, and independent working style.
• Excellent stakeholder management and communication (English C1, German B2).

Responsabilidades

• Lead and develop the Regulatory Affairs team.
• Oversee international submissions, product approvals and market access.
• Coordinate technical documentation and conformity assessment activities.
• Collaborate with quality, medical affairs and R&D.
• Drive regulatory process improvements and QMS-related activities.
• Manage priorities, resources and team responsibilities.

Conhecimentos

Regulatory Affairs

Medical devices

Leadership experience

International market access

Quality Management Systems

Documentation & conformity

Stakeholder management

English C1

German B2

Travel up to 10%

Formação

University degree in natural sciences, engineering or medicine

Descrição da vaga

For our client, an internationally operating MedTech company in Berlin, we are exclusively searching for an experienced Team Lead Regulatory Affairs (m/f/d).

This role combines regulatory expertise, people leadership and process ownership. You will lead an experienced Regulatory Affairs team, oversee international market access activities and work closely with Quality, Medical Affairs, R&D and other key functions.

The position offers the opportunity to influence how Regulatory Affairs is structured, developed and executed within an international organization focused on minimally invasive medical technologies.

Your Responsibilities

• Lead and develop the Regulatory Affairs team
• Oversee international submissions, product approvals and ongoing market access
• Coordinate technical documentation and conformity assessment activities
• Work closely with notified bodies, competent authorities and international stakeholdersEnsure timely preparation of declarations, certificates and approval-related documentation
• Support audits and collaborate closely with Quality Management and Medical Affairs
• Drive continuous improvement of regulatory processes, workflows and QMS-related activities
• Manage priorities, resources and responsibilities within your area

What You Bring

• University degree in Natural Sciences, Engineering, Medicine or a comparable field
• Several years of Regulatory Affairs experience within the medical device industry
• Strong knowledge of international market access, technical documentation and conformity assessment
• Experience working with notified bodies and regulatory authorities
• Sound understanding of Quality Management Systems and audit processes
• Previous leadership experience or clear readiness to take on people management responsibility
• Structured, independent and proactive working style
• Strong stakeholder management and communication skills
• English at C1 level and German at B2 level or higher
• Willingness to travel occasionally, up to approximately 10%

Why This Role Is Interesting

This is an opportunity for an experienced Regulatory Affairs professional who wants to move beyond pure execution and take broader responsibility.

You will have the opportunity to:

• shape Regulatory Affairs processes and structures
• influence international market access activities
• work directly with senior internal and external stakeholders
• develop and lead a Regulatory Affairs team
• contribute to product launches and long-term compliance
• work at the intersection of Regulatory Affairs, Quality, Medical Affairs and R&D

What You Can Expect

• Full-time leadership position
• Location: Berlin (hybrid Model)
• International MedTech environment
• Broad regulatory scope and real ownership
• Direct influence on processes and team development
• Close collaboration with cross-functional teams
• International exposure and occasional travel

Our Recruitment Process

Zabel is managing this search on an exclusive basis.

You will first have a confidential conversation with us to understand the role, the company and whether the opportunity fits your next career step.

Throughout the process, we will remain your dedicated point of contact and support you from the initial conversation through to the final decision.