Consultant Medical Product Excellence

Arcondis AG seeks a Consultant for Medical Product Excellence to support project leads in regulatory readiness, validation, and lifecycle management within the MedTech sector.

This position supports project leads in delivering Medical Product Excellence engagements. The role centers on managing product lifecycles, ensuring regulatory compliance, and conducting validation activities to help clients meet industry standards.

Responsibilities

• Carry out assigned work packages under supervision, focusing on product lifecycle management, regulatory compliance, and validation tasks.
• Help assess product lifecycle status and prepare for regulatory requirements.
• Plan, document, and analyze evidence generation efforts.
• Participate in clinical validation work and technical research initiatives.
• Use analytical methods to resolve structured problems within a set scope.
• Maintain quality standards and adhere to regulatory and internal organizational rules.
• Handle routine tasks independently while seeking guidance for more complex issues.
• Assist with client communications and project-related interactions.
• Develop a deeper understanding of client objectives and the regulatory landscape.
• Apply basic knowledge of product lifecycle, regulatory, and clinical domains.
• Follow established processes, methodologies, and tools.
• Help create templates and tools for clinical, regulatory, and product deliverables.

Requirements

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, or a related discipline.
• 1–3 years of experience with an MD or PhD, or 3–5 years with a Bachelor’s/Master’s, in MedTech, regulatory affairs, or clinical development.
• Prior exposure to product lifecycle or regulatory projects is required.
• Solid grasp of product lifecycle management and regulatory fundamentals.
• Working knowledge of the intersection between medical and regulatory compliance.
• Foundational understanding of medical device requirements engineering, risk analysis, or usability engineering.
• Basic familiarity with clinical validation and evidence generation.
• Strong analytical abilities to structure and interpret data.
• Capacity to support problem-solving within defined boundaries.
• Developing structured and systematic thinking skills.
• Effective communication and collaboration abilities.
• Skill in preparing structured documentation and presentations.
• Ability to thrive in cross-functional and interdisciplinary teams.
• Fluent proficiency in English.
• Capability to manage tasks and deadlines with guidance.
• Willingness to learn, accept feedback, and continuously improve skills.
• Adaptability to new tools, technologies, and regulatory changes.

Nice to have

• MD or PhD qualification is preferred for technical roles.
• Familiarity with FDA and/or EU MDR regulations is advantageous.

About the company

Arcondis AG is a medium-sized international consulting firm exclusively focused on the healthcare and life sciences industries. Since 2001, the company has helped clients navigate challenges in compliance, business processes, IT, and digital transformation. Owned by a charitable foundation, Arcondis is committed to social causes and operates under the motto 'We make healthcare better.'

• The company fosters a collaborative, innovative, and community-oriented culture.
• Leadership leads by example, demonstrating dedication to the mission and values.
• Arcondis embraces diversity and inclusivity.
• The organization is dedicated to giving back to the community through its foundation ownership.