Scientist - Design Control Documentation (Medical Devices, Remote)

Job summary

This role involves the development and maintenance of design control documentation for medical devices used in diagnostic applications, particularly in tissue-based pathology assays. The position requires collaboration with cross-functional teams to ensure compliance with regulatory standards.

Qualifications

• Master's degree or higher in a relevant field (e.g., Biochemistry, Biomedical Engineering).
• Experience in design control documentation within the medical device sector.
• Knowledge of regulatory standards such as ISO 13485 and FDA 21 CFR Part 820.
• Familiarity with immunohistochemistry and ISH/FISH molecular assays is preferred.
• Strong attention to detail and organizational skills.
• Ability to work both independently and collaboratively.
• Proficient in written and verbal English communication.

Responsibilities

• Develop, review, and maintain design control documentation in line with regulatory requirements.
• Write Design Input and Output documentation, Production Transfer documentation, and related protocols and reports.
• Collaborate with teams to ensure documentation accuracy and completeness.
• Provide expertise in documentation standards and practices during the design and development process.
• Ensure timely updates and revisions of documentation as necessary.

Skills

• Strong organizational and detail-oriented skills.
• Excellent communication skills in English.

Education

• Master's degree or higher in a relevant scientific discipline.

Tools

• Familiarity with design control documentation tools and regulatory compliance software.