Development and Manufacturing Expert

Job Title :

Medical Device Specialist

Job Description

The Medical Device Specialist will act as a drug device combination expert, responsible for planning and coordinating the implementation of medical devices manufacturing processes for new molecules under development in external contract development and manufacturing organizations (CDMOs).

This role requires collaboration with the development team and third-party companies during device development stages, as well as regulatory submissions. The successful candidate will have experience in operations, research and development, or medical affairs, specifically in the development and manufacturing of medical devices.

Key Responsibilities :

• Search and selection of new technologies, suppliers, and CDMOs for the development and assembly of medical devices.
• Collaboration in generating medical device design history files (DHF) and related documentation.
• Authoring of tech transfer protocols and reports for medical device manufacturing in selected CDMO.
• Scientific support during medical device development, assembly process tech transfer, and validation. Deviation root cause and impact assessment, as well as corrective actions (CAPAs).
• Coordination of medical device assembly process implementation and validation at CDMO.
• Generation of risk assessments, process descriptions, bills of materials, manufacturing procedures, and sampling plans compliant with regulatory standards and guidelines.
• Support of regulatory submission process, including subject matter expert input and / or revision of relevant dossier sections and participation in regulatory agency interactions.
• Leadership of evaluation and implementation of process improvements and scale-ups. Support in regulatory variation procedures.

Requirements and Personal Skills

The ideal candidate will possess a university degree in biotechnology, biochemistry, chemical engineering, or a related field. Fluency in English is required, with knowledge of other languages being an asset.

Minimum 5 years of experience in operations, R&D, or MSAT in the development and manufacturing of medical devices, preferably prefilled syringes coupled with needle safety devices and autoinjectors.

Experience in project management and scale-up to industrial manufacturing, work in a good manufacturing practice (GMP) environment, DHF generation, and regulatory filing (ICH, EMA, and FDA requirements), tech transfer, and process validation are essential.

Benefits

We offer a permanent contract to join a growing pharmaceutical company.

Equal Opportunities

Our company is committed to equal opportunities. We do not discriminate against any person on the grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.