R&D Associate

Job Description:

The R&D Associate prepares product and project documentation in compliance with the internal Quality System's procedures and applicable directives and standards (e.g., MDR; FDA 21 CFR 820; ISO 13485; ISO 14971). The R&D Associate is expected to lead small local projects.

Job Requirements:

Responsibilities

Documentation: Develop and maintain detailed product and project documentation (protocols, reports), ensuring compliance with internal Quality System procedures and relevant regulatory standards.

Labeling: Create, review, and update labeling redlines to ensure compliance with regulatory requirements and internal standards.

Project Management: Lead small local projects from initiation to completion, ensuring timely delivery and adherence to project plans.

Research and Development: Assist in the design and development of new medical devices and improvements to existing products.

Regulatory Compliance: Ensure all documentation and processes comply with applicable directives and standards (MDR, FDA 21 CFR 820, ISO 13485, ISO 14971). Prepare documentation for regulatory assessment and cooperate with regulatory affairs.

Collaboration: Work closely with cross-functional teams, including engineering, regulatory affairs, and quality assurance, to gather information and ensure documentation accuracy. Supervise internal and external testing activities. Communicate with external labs, consultants to support ongoing projects.

Requirements

Technical High School Diploma or equivalent in a relevant field (e.g., Engineering, Biomedical Sciences, Technical Writing).

Technical Writing: Excellent writing skills with the ability to create clear and concise documentation.

Regulatory Knowledge: Understanding of regulatory requirements and standards for medical devices is an advantage.

Project Management: Ability to manage small projects, including planning, execution, and monitoring.

Attention to Detail: High level of accuracy and attention to detail in all aspects of work.

Analytical Skills: Ability to analyze data and technical information to support documentation and project development.

Collaboration: Effective communication and teamwork skills to work with cross-functional teams.

Organizational Skills: Organizational skills to manage multiple tasks and projects simultaneously.

Technical Proficiency: Proficiency in using documentation management systems and software tools (e.g., Microsoft Office, Adobe Acrobat).

Communication: Good communication skills, both written and verbal in English and Czech are required.

Operating Company:

Kerr

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