Lead Regulatory Affairs Specialist (Medical Devices)

TL;DR

Lead Regulatory Affairs Specialist (Medical Devices): Ensuring medical devices and their development processes meet global regulatory requirements with an accent on regulatory submissions, approvals, and compliance. Focus on managing technical documentation, interpreting standard requirements, and coordinating cross-functional teams for market access.

Location: Must be based in Berlin, Germany

Company

hirify.global provides engineered components and sub-systems for healthcare and advanced manufacturing, specializing in minimally invasive surgery and robotics.

What you will do

• Manage the compilation and submission of approval-relevant documents, including free sales certificates and declarations, for global markets.
• Control and review technical documentation, risk analysis, clinical evaluations, and software documentation as part of the conformity assessment.
• Support the development of design control processes and the implementation of risk management and usability files.
• Act as the primary interface between the company, notified bodies, and regulatory authorities.
• Process safety-related complaints in collaboration with the Medical Affairs team.
• Maintain and adapt the Quality Management System (QMS) to ensure strict regulatory compliance.

Requirements

• 5-8 years of extensive professional experience in regulatory affairs for medical devices.
• Degree in natural sciences, engineering, medical, or a comparable field.
• Advanced training as a "Manager Regulatory Affairs for Medical Devices".
• English: C1 level required.
• German: B2 level required.
• Location: Must be based in Berlin, Germany.

Culture & Benefits

• Culture that embraces teamwork, collaboration, and empowerment.
• Opportunity to work on innovations transforming healthcare and advanced manufacturing.
• Equal employment opportunity and affirmative action workplace.
• Global team environment with a network of 26 offices worldwide.