Clinical Affairs Specialist (MedTech)

TL;DR

Clinical Affairs Specialist (MedTech): Planning and executing clinical studies for medical devices with an accent on EU-MDR compliance and PMCF activities. Focus on managing investigator-initiated studies, coordinating cross-functional teams, and ensuring regulatory compliance for life-saving technology.

Location: Hybrid (Rastatt, Germany), with 3-4 days of mobile working allowed

Company

hirify.global provides hospitals and life science institutions with products and solutions for intensive care, cardiovascular procedures, operating rooms, and sterile reprocessing.

What you will do

• Plan, design, execute, and manage clinical studies for medical devices.
• Manage Investigator-Initiated Studies (IIS), including application review, contract negotiation, and close-out.
• Execute PMCF activities, analyzing clinical, registry, and real-world data to prepare regulatory reports.
• Develop and maintain clinical documentation such as study plans, protocols, and final reports in compliance with regulatory requirements.
• Oversee external service providers, specifically Contract Research Organizations (CROs).
• Collaborate with Clinical Risk Management, Regulatory Affairs, and Medical Affairs to ensure safety and performance data generation.

Requirements

• University degree in life sciences, medicine, or a related health field.
• 3–5 years of professional experience in Clinical Affairs or clinical research, preferably in the medical device industry.
• Solid experience with EU-MDR and strong knowledge of ISO 14155 and GCP frameworks.
• Proven experience in managing CROs and collaborating with cross-functional internal teams.
• Fluent English (written and spoken).
• Must be based in or be able to work from the Rastatt, Germany office.

Culture & Benefits

• Compensation in accordance with the Metal Industry collective agreement.
• 30 days of annual vacation.
• Flexible, family-friendly working hours and mobile working options.
• JobRad bicycle leasing and Corporate Benefits employee discounts.
• Individual onboarding and professional development opportunities within a renowned global company.