Regulatory Officer

at  ODIN VISION

A Regulatory Officer shall carry out the following list of non-exhaustive activities:

• Author and maintain technical files in an organized and searchable way.
• Provide regulatory support for assigned medical devices within the Company’s portfolio of products, including but not limited to advice to engineering, AI/ML and medical affairs teams on regulatory views of new products, features or changes.
• Collect and manage data, supporting requirements analysis and documentation, end user testing, verification and validation.
• Participate in risk management activities.
• Maintain the labelling register and support the review of labelling material including marketing claims.
• Support Vigilance Reporting and Field Safety Corrective Action.
• Support Post-Market Surveillance.
• Maintain the list of registered devices and actors involved in the regulatory processes.
• Periodically assess the contents of Design History Files.
• Perform regular reviews of regulations, international standards and guidelines to highlight gaps and/or opportunities for continuous improvement of relevant technical documentation and the QMS, as well as support implementation with the subject specialists.
• Support the implementation and maintenance of the quality management system (QMS) in line with regulatory approvals and markets of interest for the Company’s software products.
• Interact with external parties, such as regulators, auditors, notified bodies, EUAR, end users, patients and external consultants on regulatory matters.

DESIRABLE QUALIFICATIONS

• Undergraduate degree in a relevant scientific or technical subject (e.g. software or biomedical engineering).
• Qualification for the implementation of relevant regulatory standards and regulations (EU, UK, US).

EXPERIENCE

• A minimum of five years working in the medical device regulatory industry.
• Knowledge of UK, EU and USA regulatory pathways.

Please refer the Job description for details