Clinical Affairs Specialist (m/f/d) - 15-month contract

About the Role Join Getinge (Maquet Cardiopulmonary GmbH) as a Clinical Affairs Specialist (m/f/d) in Rastatt within the Quality Assurance/Regulatory team. This is a 15-month contract with hybrid work (3-4 days at home). You will help drive clinical evidence generation for medical devices and ensure regulatory compliance across clinical activities. What You'll Do

• Independently plan, design, execute, manage, and close clinical studies under the leadership of a Senior Clinical and Medical Affairs Manager.
• Drive and coordinate study activities with cross-functional teams (Medical Affairs, Regulatory Affairs, Quality) and the broader Clinical/Medical Affairs organization.
• Independently manage Investigator-Initiated Studies (IISs): review applications, evaluate proposals, present in IIS committee, draft contracts, negotiate, and oversee execution through to study close-out.
• Plan, design, and execute high-quality clinical surveys and data requests to support clinical evidence generation and post-market activities.
• Plan and execute PMCF activities, including analysis of clinical, registry, and real-world data and preparation of regulatory-compliant PMCF plans and reports.
• Develop, review, and maintain clinical documentation (clinical study plans, protocols, PMCF documents, final reports) in line with applicable regulatory requirements.
• Manage and oversee external service providers, particularly CROs.
• Ensure compliance with regulatory requirements (EU-MDR, ISO 14155, GCP) within the assigned scope.
• Support clinical risk management through coordination with Clinical Risk Management and participation in risk-minimization measures related to clinical studies.
• Identify opportunities for process improvements and contribute to Clinical Affairs standards/workflows (e.g., SOP updates).
• Collaborate with Clinical Risk Management and other Clinical/Medical Affairs colleagues on clinical studies and literature reviews for safety and performance data generation for device documentation (approximately 20% of the role). What We're Looking For
• University degree in life sciences, medicine, or a related health field (or equivalent qualification).
• 3–5 years of professional experience in Clinical Affairs/clinical research, preferably within the medical device industry.
• Solid experience conducting clinical studies and PMCF activities in accordance with EU-MDR.
• Strong knowledge of regulatory frameworks (EU-MDR, ISO 14155, GCP).
• Experience managing external partners (e.g., CROs) and collaborating with cross-functional internal teams.
• Strong project management skills with the ability to manage multiple priorities.
• Structured, quality-driven, and self-reliant working style.
• Excellent communication skills and confidence working in an international environment.
• Fluent English (written and spoken). Compensation & Benefits
• Compensation in accordance with the Metal Industry collective agreement.
• 30 days of annual vacation and additional attractive benefits.
• Flexible, family-friendly working hours and mobile working options.
• JobRad bicycle leasing and Corporate Benefits (employee discounts).
• Career opportunities within a renowned company.
• Individual onboarding and professional development opportunities.
• Modern workplace equipment and infrastructure. About Us Getinge believes every person and community should have access to the best possible care. We provide hospitals and life science institutions with products and solutions to improve clinical results and workflows across intensive care, cardiovascular procedures, operating rooms, sterile reprocessing, and life sciences. Getinge employs over 12,000 people worldwide and serves more than 135 countries.