Regulatory Officer

6 months ago

London, United Kingdom Odin Vision Full time

**Regulatory Officer - UK/Hybrid**:
Odin Vision is a pioneering, multi-award-winning company that specializes in the development of cutting-edge AI-enabled software for endoscopic procedures. Our mission is to aid clinicians in the detection and diagnosis of diseases, thereby supporting superior quality care, enhanced patient outcomes, and greater value for healthcare payers.

We are currently seeking a detail-oriented and experienced Regulatory Officer to join our dynamic team. This position is vital for ensuring our products meet all regulatory, legal, and ethical standards in healthcare markets, particularly within the Medical Devices sector.

This is a full-time, hybrid role, necessitating occasional international travel.

**Salary range - £50k - £60K depending on experience**

**What you'll do**:
A Regulatory Officer shall carry out the following list of non-exhaustive activities:

- Supporting the implementation and maintenance of quality management system to support CE and FDA regulatory approvals for the Company's software product, this includes, but is not limited to, interacting with auditors, notified bodies, EUAR, end users, patients and external consultants;
- Collect and manage data, supporting requirements analysis and documentation, end-user testing, verification and validation.
- Log any non-conformities raised on the system
- Maintain up-to-date register of labelling
- Author and maintain technical files in an organised and searchable way
- Authorise and issue documents
- Periodically assess the contents of the Design History File
- Support Vigilance Reporting and Field Safety Corrective Action
- Support Post
- Market Surveillance
- Participate in risk management activities

**Qualifications**:

- An undergraduate degree, or equivalent in a regulatory, scientific, healthcare, or related field.
- Professional certification or training in regulatory affairs is highly desirable.

**Required experience**:

- Previous experience in regulatory affairs within the medical devices sector, particularly software as a medical device (SaMD).
- Proven track record of successful interactions with regulatory bodies like the MHRA, FDA, or EMA.
- Experience in the preparation and submission of regulatory documentation for product approvals.
- Knowledge of the current EU Medical Device Regulation (MDR), UK Medical Devices Regulations, and other international regulatory frameworks.

**Desirable for the role**:

- Strong understanding of the quality management systems such as ISO 13485 and ISO 14971.
- Experience with regulatory strategy and implementation for global markets.
- Excellent communication and project management skills.
- Ability to work effectively in cross-functional teams and manage multiple projects simultaneously.

Odin Vision is committed to championing equality, diversity, and inclusion within our workforce, eliminating unlawful discrimination. We aspire to have a diverse team, fully representative of all sections of society and our customer base, providing an environment where everyone feels valued and can perform at their best.

**Regulatory Officer - UK/Hybrid**:
**Learn more about us**:

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