Product Lifecycle Manager - Medical Device (m/w/d)

About this role

Location:Nieder-Olm, DE

Job Family: Marketing

Country/Region: Germany

EN - Job Advertisement

We are a medium‑sized, fast‑growing company with around 300 employees in the medical device industry, headquartered in Nieder‑Olm near Mainz. Due to our high level of expertise, we are a national market leader in our field and continue to experience steady growth in the international market. Flat hierarchies, short communication channels, innovative strength, and open doors characterize our company culture.

At the earliest possible date, we are looking for a candidate for our Nieder‑Olm site as

Product Lifecycle Manager – Medical Devices (m/f/d)

Scope of position: Full‑time, 40 hours per week / 1.0 FTE

Type of employment: Fixed‑term employment due to parental leave

Location: TRACOE medical GmbH, 55268 Nieder‑Olm / Germany

Application deadline: until 17 May 2026

Our role – your mission

As a Product Lifecycle Manager, you ensure that our medical device portfolio remains regulatory compliant, safe, and future‑proof throughout its entire lifecycle. You manage design and change processes, keep our technical documentation up to date, and balance regulatory, quality, and business requirements. In doing so, you work closely with R&D, Quality, Regulatory Affairs, and Operations.

Your tasks and responsibilities

• Managing product and design changes throughout the entire lifecycle – including project management and the creation of regulatory‑compliant documentation (EN ISO 13485, EU‑MDR, 21 CFR 820, MDSAP)
• Maintaining and further developing the Design History Files (DHF) as well as the technical documentation for medical devices of classes Is/m to IIa/b
• Ensuring complete traceability from user needs to design inputs/outputs through to verification, validation, and risk management
• Acting as the technical point of contact for Design Control & Lifecycle Management for all relevant stakeholders
• Contri...