Lead Regulatory Affairs Specialist (Medtech)

TL;DR

Lead Regulatory Affairs Specialist (Medtech): Managing regulatory approval processes and design control for medical devices with an accent on compliance, risk management, and clinical evaluation. Focus on coordinating cross-functional teams, interfacing with notified bodies, and ensuring adherence to international medical device standards.

Location: Berlin, Germany (Onsite)

Company

hirify.global is a global leader in precision engineered components and sub-systems for medical and advanced industrial applications.

What you will do

• Manage the compilation of approval-relevant documentation for medical devices worldwide.
• Oversee design control processes, including risk analysis, clinical evaluation, and usability files.
• Act as the primary interface between customers, notified bodies, and regulatory authorities.
• Support audits and ensure compliance with quality management systems.
• Process safety-related complaints in collaboration with the Medical Affairs team.
• Provide subject matter expertise on standards for electrical safety, biocompatibility, and cybersecurity.

Requirements

• 5-8 years of extensive professional experience in regulatory affairs.
• Degree in natural sciences, engineering, or a medical field.
• Advanced training as a Manager Regulatory Affairs for Medical Devices.
• English proficiency at C1 level required.
• German proficiency at B2 level required.
• Ability to travel up to 10% of the time.

Culture & Benefits

• Global team environment with a focus on teamwork and empowerment.
• Opportunity to work on mission-critical innovations in minimally invasive medicine.
• Commitment to equal employment opportunity and inclusive workplace policies.