Your responsibilities

Leadership & Team Management:
- Responsible for the extremities product and service portfolio strategy and implementation 
- Lead and coach our product management team responsible for the extremities product lines
- Promote a culture of compliance, collaboration and continuous improvement
- Ensure cross-functional coordination and alignment across R&D and Innovation, Quality & Regulatory, Supply Chain and Commercial teams

Design Control & Regulatory Compliance:
- Ensure product development complies with the Design Control requirements of ISO 13485 and 21 CFR Part 820
- Ensure systematic capture and consolidation of customer and market needs as the basis for design input requirements
- Ensure development documentation supports audit-readiness and regulatory submissions

User Documentation:
- Responsible for the User Documentation (e.g. IFUs, manuals)
- Ensure consistency with design outputs, risk management and regulatory requirements
- Manage updates and version control of user documents throughout the product lifecycle

Life Cycle Management & Continuous Improvement:
- Manage all Life Cycle Management (LCM) activities for the extremitiy product portfolio
- Lead product updates, change control processes and sustaining engineering projects
- Drive improvements based on post-market data and internal feedback loops

Stakeholder & Interface Management:
- Act as primary interface with R&D and Innovation, and coordinate closely with Regulatory Affairs, Quality, Clinical Affairs, Operations and Marketing
- Ensure that all development and LCM activities are aligned with internal procedures and external regulatory expectations
- Maintain strong communication with key stakeholders globally

Your qualifications

- Bachelor or Master's Degree in Engineering, Life Sciences or related field
- 8+ years of experience in the development of regulated medical devices
- Proven leadership experience and strong knowledge of ISO 13485 and 21 CFR Part 820
- Experience in Life Cycle Management, design control, and post-market activities
- Strong ability to manage and influence in a matrix organisation with multiple stakeholders and reporting lines
- Excellent communication skills in English and German
- Structured, analytical and quality-oriented mindset
- Occasional travelling required

What we offer

This is an integral, responsible and diversified role with a focus on quality and service provision in a rapidly growing, international company. We look forward to receiving your complete application.

About Medartis

Medartis is a leading medical device manufacturer specializing in high-precision implants for the surgical fixation of bone fractures, fusions, and osteotomies. Our motto of "Precision in Fixation" is our commitment to innovative development and stringent quality standards with the goal of improving the patient's quality of life.

For further information please visit our Website www.medartis.com.

We look forward to receiving your complete online application.