Clinical Affairs Specialist (mfd)

Senior Clinical Affairs Specialist (m/f/d)

We are seeking a Senior Clinical Affairs Specialist to support Strykers Instruments Division. The role will support the Craniomaxillofacial (CMF) business unit which has a well-earned reputation as a market leader for innovative developments providing instrumentation and implantable medical devices in cranial maxillofacial and sternal closure procedures. Together we restore form function and hope to patients around the world.

In this role at our Freiburg site you will lead the planning creation and maintenance of Clinical Evaluation documents. As the lead technical expert you will apply your scientific regulatory and project management expertise to compile and assess the Clinical Evidence that underpins conclusions on product safety and performance throughout the entire lifecycle. You will work closely with the Medical Expert to reach sound scientific decisions.

In this role at our Freiburg site you will play the lead role in the planning creation and update of Clinical Evaluation documents. You will act as the technical expert in driving this highly complex and demanding process. You will apply your scientific regulatory and project management skills to compile the body of Clinical Evidence on which you in collaboration with the Medical Expert will reach scientific conclusion on the safety and performance of our products in patients throughout the entire product lifecycle.

Your key responsibilities

• Lead the and drive the clinical evaluation process and develop and update Clinical Evaluation deliverables (CEP CER SSCP PMCF Plan & Report).
• Develop compliant sustainable literature search strategies; perform complex literature reviews; and analyze the current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques
• Serve as the Clinical Evaluation Project Manager supporting the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle and fostering alignment with adjacent complex processes (Marketing strategy and claims regulatory strategy clinical research strategy testing strategy).
• Develop define and defend appropriate clinical strategies to support international regulatory approvals.
• Contribute throughout the full product lifecycle supporting both new product development and postmarket surveillance.
• Act as the subject matter expert for clinical questions and collaborate closely with R&D Regulatory Clinical Research Quality and Marketing.
• You will support the team in continuously developing our Clinical Evaluation and analyses methodologies to adapt to a complex and quickly evolving regulatory framework .

What we are looking for

Your background

• University degree (PhD MD Masters or equivalent) in life sciences or a relevant medical engineering field.
• Several years of clinical or academic research experience with a strong performance record.
• Proven medical/scientific writing experience
• Experience in data analysis and statistics
• Experience in a regulated environment (medical devices Regulatory Affairs Quality Clinical Affairs) is preferred.
• Solid knowledge of Clinical Evaluation regulations and guidelines (MEDDEV 2.7/1 Rev. 4 EU MDR MDCG TGA) is preferred
• Experience with the design and analysis of clinical studies is a plus.

Your skills

• Able to work independently make sound decisions and lead complex projects.
• Excellent communication and stakeholdermanagement skills across all organizational levels.
• Strong analytical mindset with the ability to interpret and synthesize and communicate complex scientific and clinical data.
• Proactive collaborative and comfortable working in international crossfunctional teams.
• Full professional proficiency in English; German fluency preferred.