Senior Scientific Affairs Manager EMEA

CLIENT DESCRIPTION

A leading company in several diagnostics niche markets including Immunochemistry, HPLC based diabetes and thalassemia screening and Molecular Biology has demonstrated technological leadership through an in-depth understanding of the ever-growing clinical demand for faster and more precise diagnosis of several life-threatening pathologies (e.g., tumour, cardiac, diabetes etc.).

The company is represented in Europe, Africa and the Middle East, among others. It is part of an international group with operations worldwide and more than 13,800 employees globally. The organization itself has approximately 180 employees in EMEA.

We are looking for a

Senior Scientific Affairs Manager (m/f/d)

The role acts as a central interface between scientific/clinical, QARA, Sales, Marketing and Strategy. You provide high-quality scientific and application support to internal and external customers, delivering evidence-based expertise across Scientific Management and Scientific Marketing, while actively supporting business growth initiatives and Sales and Marketing activities throughout the entire product lifecycle.

You provide high-quality application support to internal and external customers, delivering science-based expertise, business growth initiatives, and marketing support throughout the whole product lifecycle.

In addition, you validate and embed newest insights on scientific trends, practices, and ethics into company processes while striving to leverage them for commercial impact, including customer relationship management integration and building brand ambassadorships. Key collaborative focus areas include scientific partners, international healthcare organizations, value-based healthcare, hospital economics, and market access.

reports to: Head of Marketing EMEA

# of employees: none

Functional responsibilities

• Scientific support of the Sales team and customers
• Scientific input into product positioning and value propositions
• Development of scientific messaging and support for product management
• Translation of evidence and scientific data into differentiation vs competition
• Represent the company in customer meetings
• Deliver technical/ subject based seminars/ lectures for customers
• Definition and implementation of the annual evaluation matrix for complex, challenging development projects for diagnostics assays and instruments
• Budget and time planning for the entire annual instrument & assay evaluation matrix
• Planning and coordination for evaluation of assays and instruments
• Monitor the execution of necessary ongoing evaluations and projects, internationally and across locations
• Represent company needs in industry-based associations and federations (e.g. IFCC)
• Provide support to QA/ RA for technical file reviews
• Ensure that all customer projects and evaluations for assays & instruments are planned and conducted in-line with the company's strategic objectives and regulatory requirements
• Nurture and develop close relationships with customers to build trust and secure long-term partnerships. These relationships are critical to the success and growth of the department
• Statistical analysis and evaluation of clinical data (hands-on)
• Creation, review and approval of product-specific scientific publications
• Continuous collaboration in project teams for new and further product developments from product definition to market launch
• Management, support and coordination of service providers in the preparation and maintenance of clinical evaluations
• Planning, creation and documentation of post-market scientific follow-up measures
• Scientific input for products with regard to safety and performance for market observation, technology assessment, etc.
• Support scientific/ regulatory affairs teams worldwide with product registration
• Review, adapt/ improve scientific affairs processes regularly
• Develop the role to excel in efficiency and expertise, by applying hands-on mentality and Senior Scientific Affairs experience and knowledge
• Ensure compliance with Code of Ethics, Quality Management System, Company Policies and Corporate Procedures.

Major interfaces: Sales, Marketing, Regulatory Affairs, Quality Management, R&D, After Sales, Customer Support

Personal:

• Scientific rigor and integrity; unbiased, compliant communication.
• Influences without authority; navigates matrix and ambiguity, able to learn fast and explain complex topics or technical aspects in a preceptor role.
• Solid business acumen in an international environment.
• Customer‑centric mindset; turns insights into evidence plans.
• Clear, crisp writing and storytelling; strong presentation and public speaking skills, with the confidence to engage large audiences.
• Senior operational excellence: prioritization, PM skills, and on‑time delivery.
• Passion for medical and especially scientific marketing, with a strategic and innovative mindset.
• Strong presentation and public speaking skills, with the confidence to engage large audiences.
• Ability to navigate diverse professional environments and collaborate effectively across teams and cultures.

Professional experience:

• Master in Science, Life Science or Biology
• 10+ years of relevant international experience – preferably EMEA region – in the IVD sector
• Experience in writing scientific publications, evaluations of medical devices, assays and development of study protocols
• Extensive active IVD industry KOL network
• Deep knowledge of disease state, clinical information, and product data for the business
• Track record in supporting business decision making on scientific evidence topics e.g. evaluation of scientific/ medical and regulatory risk, investments, etc.
• Practical experience in project management and medical writing
• Sound knowledge of the relevant regulatory requirements for multiple kinds of scientific studies and evaluations in clinical diagnostics as well as experience and proven success in the design of clinical studies
• Excellent verbal and written skills in English (minimum B2 level).
• Proficiency in MS Office and common software tools.
• Willingness to travel 30-50% (mostly in the EMEA region)

KEY REASONS WHY THIS POSITION IS ATTRACTIVE TO POTENTIAL CANDIDATES

I. A challenging position in a great and international team with an effective and energetic work atmosphere

II. The ability to work autonomously in a flexible and innovative environment, directly contributing to customer satisfaction and ultimately, business success.

III. An attractive salary package including extra-legal benefits and learning and development opportunities

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