Documentation Specialist

About the Position:

• The successful candidate will be responsible for creating, maintaining and updating documentation related to Design Input, Design Output and Technical Files.
• This individual will ensure that documentation meets the required ISO standards applicable to medical devices.
• Support will be provided in preparing and maintaining documents necessary for regulatory submissions.
• Collaboration with cross-functional teams will be essential in gathering and validating information for technical documentation.
• Quality records will be maintained and controlled, ensuring traceability and accuracy as per ISO 13485 and associated guidelines.
• Assistance will be provided in internal and external audits by providing the necessary documentation.

Required Skills:

• Strong knowledge of ISO standards (ISO 13485).
• Hands-on experience in medical device documentation.
• A good understanding of regulatory requirements for medical devices is essential.
• Excellent attention to detail, organizational and communication skills are required.
• Proficiency in MS Office and documentation management tools is necessary.