Post Market Surveillance Specialist (Medical Devices)

TL;DR

Post Market Surveillance Specialist (Medical Devices): Managing vigilance activities and post-market clinical follow-up for advanced surgical medical devices with an accent on regulatory compliance and adverse event reporting. Focus on evaluating benefit-risk ratios, conducting health-risk assessments, and ensuring strict adherence to MDR requirements.

Location: Berlin, Germany (Hybrid)

Company

hirify.global is a global leader in precision engineered components and sub-systems for mission-critical applications in healthcare and advanced manufacturing.

What you will do

• Evaluate adverse events and determine reporting obligations based on international regulatory standards.
• Manage vigilance data, perform literature reviews, and update PMS/PMCF documentation.
• Conduct health-risk assessments and support benefit-risk ratio evaluations.
• Serve as the primary point of contact for authorities and customer inquiries regarding vigilance.
• Update and maintain Vigilance-related SOPs in compliance with MDR and international standards.
• Coordinate recall and FSCA processes when necessary.

Requirements

• University degree in life science or natural science.
• Professional experience in the medical device environment or regulatory field.
• Proven experience in risk assessment and reporting adverse events.
• Knowledge of international regulatory requirements for vigilance activities.
• Fluent English proficiency required.
• Ability to coordinate complex workflows with a structured and systematic approach.

Nice to have

• German language skills.
• Experience in regulatory medical writing.
• General QMS knowledge.

Culture & Benefits

• Global team environment with over 26 offices worldwide.
• Culture focused on teamwork, collaboration, and empowerment.
• Opportunities to work on innovative technology transforming healthcare.
• Commitment to equal employment opportunity and affirmative action.