Clinical Affairs Specialist (m/f/d) (limited to 15 months)

With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

We offer you a position within Maquet Cardiopulmonary GmbH in the Quality Assurance/Regulatory department at our Rastatt location as a

Clinical Affairs Specialist (m/f/d) (limited to 15 months) Your Responsibilities

• Independently plan, design, execute, manage, and close clinical studies for medical devices under the functional leadership of a Senior Clinical and Medical Affairs Manager
• Drive and coordinate study activities in close collaboration with cross-functional teams (e.g., Medical Affairs, Regulatory Affairs, Quality) and the broader Clinical and Medical Affairs organization
• Independently manage Investigator-Initiated Studies (IISs): review applications, evaluate proposals, presentation in IIS committee, draft contracts and negotiation and ensure successful 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 (Post-Market Clinical Follow-up) 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 in compliance with applicable regulatory requirements (e.g., clinical study plans, protocols, PMCF documents, final reports)
• Manage and oversee external service providers, particularly Contract Research Organizations (CROs)
• Ensure compliance with applicable regulatory requirements (especially EU-MDR, ISO 14155, GCP) within the assigned scope of responsibility
• Support clinical risk management activities through close coordination with Clinical Risk Management and participation in risk-minimization measures related to clinical studies
• Identify opportunities for process improvements and actively contribute to the enhancement of Clinical Affairs standards and workflows (update of SOPs, etc)
• Close collaboration with Clinical Risk Management, including participation in risk-minimization activities associated with clinical studies and clinical evidence generation
• Collaborate closely with Clinical and Medical Affairs colleagues on all matters related to clinical studies, literature reviews for safety and performance data generation for device documentation (20% of the role)

Your Profile

• University degree in life sciences, medicine, or a related health field (e.g., biology, biochemistry, life sciences, human medicine, public health) or equivalent qualification
• 3–5 years of professional experience in Clinical Affairs / clinical research, preferably within the medical device industry
• Solid experience in conducting clinical studies and PMCF activities in accordance with EU-MDR
• Strong knowledge of regulatory frameworks (EU-MDR, ISO 14155, GCP)
• Experience in managing external partners (e.g., CROs) and collaborating with cross-functional internal teams
• Strong project management skills with the ability to manage multiple priorities effectively
• Structured, quality-driven, and self-reliant working style
• Excellent communication skills and confidence working in an international environment
• Fluent English (written and spoken)

We Offer You

• High-quality products in a life-saving environment
• 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 B