Lead Regulatory Affairs Specialist (Medtech)

TL;DR

Lead Regulatory Affairs Specialist (Medtech): Managing regulatory submissions and ensuring compliance for minimally invasive medical devices with an accent on technical documentation and design control. Focus on coordinating cross-functional teams, interpreting standard requirements for clinical evaluation, and managing interfaces with notified bodies and authorities.

Location: Berlin, Germany

Company

hirify.global is a global company producing high-precision engineered components and sub-systems for healthcare and advanced manufacturing.

What you will do

• Manage the compilation of approval-relevant documents and coordinate evaluations by notified bodies and competent authorities worldwide.
• Control and release technical documentation as part of the conformity assessment procedure and declarations of conformity.
• Review and release design control documents, including risk analysis, clinical evaluations, design validation/verification plans, and software documentation.
• Perform regulatory evaluations of change orders and act as a Subject Matter Expert for requirements regarding biocompatibility, electrical safety, and cybersecurity.
• Serve as the primary interface between the RA departments of customers, notified bodies, and regulatory authorities.
• Process safety-related complaints in cooperation with the Medical Affairs team.

Requirements

• 5-8 years of extensive professional experience in regulatory affairs.
• Degree in natural sciences, engineering, medical, or a comparable field.
• Advanced training as a "Manager Regulatory Affairs for Medical Devices".
• English: C1 level and German: B2 level.
• Location: Must be based in Berlin, Germany.
• Willingness to travel up to 10%.

Culture & Benefits

• Culture that embraces teamwork, collaboration, and empowerment.
• Opportunity to work on innovations that redefine possibilities in healthcare and robotics.
• Participation in a global team with over 26 offices across the Americas, Europe, and Asia-Pacific.