Consultant Medical Product Excellence

Náplň práce, právomoci a zodpovednosti:

The Consultant Medical Product Excellence supports the delivery of projects across product lifecycle management, regulatory readiness, and clinical validation.

This role focuses on analytical work, documentation, and operational execution while building foundational expertise in Medical Product Excellence. The Consultant works under guidance of senior team members and gradually develops autonomy in executing work packages, supporting client interactions, and contributing to service development.

Key Responsibilities

Delivery / Project Work

• Contribute to project deliverables and support project leads in Medical Product Excellence engagements
• Execute work packages with guidance across product lifecycle management, regulatory readiness, and validation activities
• Support product lifecycle and regulatory readiness assessments
• Assist in evidence-generation planning, documentation, and analysis
• Contribute to clinical validation activities and technical research
• Apply analytical skills to solve structured problems within defined scope
• Ensure quality and compliance with regulatory and organisational standards

Client Interaction & Application of Expertise

• Perform routine tasks independently with guidance for more complex activities
• Support project-related client interactions and communication
• Build understanding of client needs and regulatory environments
• Apply foundational knowledge in product lifecycle, regulatory, and clinical domains
• Follow established processes, methodologies, and tools

Service Development & Capability Contribution

• Support development of templates and tools for clinical, regulatory, and product-related deliverables
• Contribute to internal knowledge management and documentation of project learnings
• Provide feedback on methodologies, tools, and ways of working
• Identify minor process inefficiencies and suggest improvements

Sales & Account Support

• Support project extensions and renewals through high-quality delivery
• Contribute to proposal development and preparation of sales materials
• Provide input based on research, analysis, and project experience

Branding & Knowledge Contribution

• Develop a professional voice and presence within the organisation
• Maintain a professional personal brand as a subject matter expert in development within Medical Products
• Contribute to internal publications, opinion pieces, and thought leadership content

Zamestnanecké výhody, benefity:

• Referral bonus depending on level of person referred
  
• Business mobile (also for private calls) and laptop
• 3 sick days per calendar year
• 2 extra days off for your wedding
• Social events (team-buildings and team-dinners)
• Budget for trainings & certifications
• Monthly events in Kosice (office)
• Free snacks & drinks in the office
• Home Office upon agreement (or possibility to work from our office in Kosice)
• Flexible working hours
• Ice Hockey ticket discounts
• Supplementary pension scheme (the third pilar) contribution
• Benefit card
• On - calls paid beyond the law
• Meal allowance beyond the law
• Company bonus (based on company financial results)

Požiadavky na zamestnanca:

Qualifications, Skills and Experience

• Master’s or Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field
• MD or PhD preferred for technical areas
• 3–5 years (with a Master’s/Bachelor’s degree) / 1–3 years (with an MD or PhD) of experience in MedTech, regulatory affairs, clinical development, or related areas
• Initial exposure to product lifecycle or regulatory projects is a must

Medical Product & Regulatory Fundamentals

• Understanding of product lifecycle management and regulatory fundamentals
• Working knowledge of medical–regulatory interface and compliance requirements
• Familiarity with FDA and/or EU MDR regulations is preferred
• Foundational understanding of medical device requirements engineering, medical risk analysis, and/or usability engineering.
• Basic knowledge of clinical validation and evidence generation

Analytical & Problem-Solving Skills

• Strong analytical skills with the ability to structure and analyse data
• Ability to support problem-solving within defined scope
• Developing structured and systematic thinking

Communication & Collaboration

• Strong communication and collaboration skills
• Ability to prepare structured documentation and presentations
• Ability to work effectively in cross-functional and interdisciplinary teams
• Fluent in English

Working Style & Development

• Ability to manage tasks and deadlines with guidance
• Willingness to learn, seek feedback, and continuously develop skills
• Ability to adapt to new tools, technologies, and regulatory environments