(Senior) Staff Clinical Affairs Specialist (mfd)

Stryker is one of the worlds leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. We are currently seeking a (Senior) Staff Clinical Evaluation Specialist to join our Instruments Division to be based in Freiburg Germany. 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.

Who we want

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity change and outcomes.

Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas data and insights to drive continuous improvement in functions.

Data translators. Highly effective communicators who can transform data findings into recommendations to compose reports and executive level presentations.

What you will do

As a (Senior) Staff Clinical Evaluation Specialist you will partner with cross-functional teams (Marketing Regulatory Reimbursement & Market Access Clinical Research Quality) to develop high-quality submission-ready clinical documentation that enables global market access. You will work independently with minimal supervision.

Key responsibilities:

Manage clinical evaluation projects and develop a clear evidence strategy across new product development. Ensure alignment with related processes such as claims regulatory strategy clinical research and preclinical testing.

Draft and update regulatory documentsincluding submissions annual reports clinical evaluations and safety summariesto confirm device safety and performance throughout the product lifecycle. Present clinical information clearly concisely and accurately.

Design compliant and sustainable literature search strategies perform systematic reviews to capture and summarize published clinical data. Analyze current medical and scientific trends in the clinical state of the art on a broad variety of specialized indications and techniques.

Form and justify conclusions regarding the overall benefit-risk profile of medical devices in collaboration with other stakeholders

Communicate and negotiate with regulators on clinical evidence requirements to ensure the successful acceptance of regulatory submissions.

Drive evidence communication in partnership with stakeholders (e.g. Marketing Clinical Research Reimbursement & Market Access) to ensure alignment with business priorities. Translate complex scientific and technical information into accessible content for various audiences.

Support clinical research activities by identifying gaps in knowledge and developing strategies for pre-clinical and clinical data collection.

Support new product development projects by helping cross-functional teams develop intended use and indication for use statements risk files and product claims.

Support sustainment projects to ensure continued product availability. Help translate clinical data into new claims for existing products.

Review marketing collateral for accuracy of clinical information product performance and safety claims.

Proactively recognize potential scheduling and resource conflicts for projects and provide recommendations to resolve. Identify and implement new strategies to enhance team efficiency.

Resolve document content issues and questions from external and internal reviewers. Manage the cross-functional review process and ensure timely approvals from all reviewers.

Support innovation and operational excellence; set direction within the team in internal procedures and best practices.

Serve as a subject matter expert within the business.

May mentor and direct work of team members.

What are we looking for

Your background

A Master of Science degree in a health/science-related field required Doctorate degree in health/science-related field preferred.

4 years of experience in research clinical quality or regulatory affairs (risk management design quality post-market safety etc.) including 3 years of experience in writing clinical evaluations for medical devices

Demonstrated ability to interpret regulations standards and technical or medical product information and to apply regulations towards developing a comprehensive market access strategy

Demonstrated ability to understand and communicate new medical topics including disease states treatment rationales surgical techniques and clinical outcomes.

Successful track record in managing complex projects.

Demonstrated ability to work effectively with cross-functional internal (Regulatory Marketing Research & Development) and external stakeholders (physicians third-parties clinical research organizations etc.).

Your skills

Excellent scientific and medical writing skills required.

Strong communication project management influencing and negotiation skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.

Motivated self-starter with the ability to work with minimal supervision and make independent decisions when limited information is available.

Strong planning and organizational skills attention to quality and the ability to adapt and adjust to changing priorities.

Analytical and problem-solving capabilities with a strong technical aptitude including the ability to draw insights from data quickly and to define executable actions.

Ability to build strong relationships by fostering open communication respect and trust.