Are you an experienced engineer with a strong background in product lifecycle management, design changes, and cross‑functional project coordination within a GMP/ISO‑regulated environment? Are you looking for a new challenge where you will support complex medical device operations and contribute to high‑impact product improvements? Read on.
Job Description
Our client is a leading international company within the medical device industry, specializing in the manufacturing of high‑quality products for aesthetic and reconstructive procedures. The organization operates in a highly regulated environment and utilizes advanced technologies for product design, material processing, and sterile manufacturing.
In this role, you will be responsible for managing product and component changes across the full lifecycle of implantable medical devices. You will ensure that design updates, labeling modifications, documentation revisions, and BOM changes are executed in accordance with GMP, ISO 13485, and design control requirements.
Responsibilities
- Lead and coordinate product design changes from initiation through release, ensuring full compliance with design control, GMP, and ISO 13485 requirements.
- Support material introductions and phase-outs with sourcing teams and suppliers.
- Drive labeling changes, facilitating content reviews with global and local experts, and ensuring alignment with regulatory and marketing needs.
- Oversee Unique Device Identification management to ensure regulatory traceability requirements are met.
- Support new product registration and commercial launch by preparing documentation and coordinating cross-functional contributions.
- Organize and lead project meetings, manage timelines and deliverables, and maintain transparent communication with stakeholders.
- Investigate and respond to product issues in the market by coordinating with R&D, QA, RA, and Marketing to drive corrective and preventive actions.
- Ensure strict adherence to SOPs, GMP, ISO 13485, and internal company procedures.
Requirements
- Bachelor's or Master's degree in an engineering discipline.
- Between 3+ years experience within medical devices or a similarly regulated manufacturing environment.
- Strong understanding of GMP, ISO 13485, and design control processes.
- Experience coordinating cross-functional technical projects involving labeling, documentation, or design change activities.
- Excellent English; Dutch is a plus.
- Strong organizational, analytical, and stakeholder management skills.
- Valid Dutch work permit is required.
Benefits
- Contract: 12 months via Oxford, extension possible
- Salary: €4000-€5000 gross monthly based on full-time
- Holidays: 25
- Region: Leiden
