<img alt="" src="https://www.getinge.com/siteassets/start/company/careers/Global_careers-portal90122.jpg"> 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: <ul style="margin-bottom:0.0cm;margin-top:0.0px" type="disc"> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">Independently plan, design, execute, manage, and close clinical studies for medical devices under the functional leadership of a Senior Clinical and Medical Affairs Manager</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">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</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">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</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">Plan, design, and execute high-quality clinical surveys and data requests to support clinical evidence generation and post-market activities</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">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</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">Develop, review, and maintain clinical documentation in compliance with applicable regulatory requirements (e.g., clinical study plans, protocols, PMCF documents, final reports)</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">Manage and oversee external service providers, particularly Contract Research Organizations (CROs)</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">Ensure compliance with applicable regulatory requirements (especially EU-MDR, ISO 14155, GCP) within the assigned scope of responsibility</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">Support clinical risk management activities through close coordination with Clinical Risk Management and participation in risk-minimization measures related to clinical studies</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">Identify opportunities for process improvements and actively contribute to the enhancement of Clinical Affairs standards and workflows (update of SOPs, etc)</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">Close collaboration with Clinical Risk Management, including participation in risk-minimization activities associated with clinical studies and clinical evidence generation</li> <li style="color:dimgray;margin-top:6.0pt;margin-bottom:0.0cm;text-align:justify;line-height:normal;margin-right:0.0cm;font-size:11.0pt;font-family:Calibri, sans-serif">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)</li> </ul> Your Profile: <ul style="margin-bottom:0.0cm;margin-top:0.0px" type="disc"> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">University degree in life sciences, medicine, or a related health field (e.g., biology, biochemistry, life sciences, human medicine, public health) or equivalent qualification</li> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">3–5 years of professional experience in Clinical Affairs / clinical research, preferably within the medical device industry</li> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Solid experience in conducting clinical studies and PMCF activities in accordance with EU-MDR</li> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Strong knowledge of regulatory frameworks (EU-MDR, ISO 14155, GCP)</li> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Experience in managing external partners (e.g., CROs) and collaborating with cross-functional internal teams</li> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Strong project management skills with the ability to manage multiple priorities effectively</li> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Structured, quality-driven, and self-reliant working style</li> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Excellent communication skills and confidence working in an international environment</li> <li style="color:#595857;text-align:justify;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Fluent English (written and spoken)</li> </ul> We offer you: <ul style="margin-bottom:0.0cm;margin-top:0.0px" type="disc"> <li style="color:#595857;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">High-quality products in a life-saving environment</li> <li style="color:#595857;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Compensation in accordance with the Metal Industry collective agreement, 30 days of annual vacation, and additional attractive benefits</li> <li style="color:#595857;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Flexible, family-friendly working hours and mobile working options</li> <li style="color:#595857;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">JobRad bicycle leasing and Corporate Benefits (employee discounts)</li> <li style="color:#595857;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Career opportunities within a renowned company</li> <li style="color:#595857;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Individual onboarding and professional development opportunities</li> <li style="color:#595857;line-height:normal;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;font-size:11.0pt;font-family:Calibri, sans-serif">Modern workplace equipment and infrastructure</li> </ul> About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Are you interested in this challenge? If so, we look forward to receiving your application. We’re happy to answer any questions you may have. Your contact: Mr. Aaron Brunsch, Phone number: +49 7471 9973 – 706 Application Information Please fill out our online application form and attach your complete application documents, which should include a cover letter, resume, employment and academic transcripts, and any other relevant certificates. Please also indicate your current notice period and your desired salary. Equal opportunity is very important to us, so we are committed to taking all necessary steps to ensure an inclusive and supportive selection process. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

Clinical Affairs Specialist (m/f/d) (limited to 15 months) (Rastatt, DE) @ Getinge Holding B.V. & Co. KG

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