Offer summary

Qualifications:

Extensive commercial experience in risk management for medical devices., In-depth knowledge of ISO 14971, ISO/TR 24971, IEC 62304, and ideally IEC 60601., Strong organizational skills with the ability to prioritize tasks effectively., Excellent verbal and written communication skills in English..

Key responsabilities:

Create and maintain Risk Management Files for medical devices, including various risk analyses and reports.

Participate in risk reviews for design changes and post-market surveillance data.

Develop risk control requirements to inform product design.

Support the company's quality policy and objectives through various related duties.

Job description

Vision RT is a rapidly growing MedTech which is transforming radiation therapy for cancer patients, helping to make it more accurate, effective and comfortable. We are the inventors of, and the market leaders in, Surface Guided Radiation Therapy (SGRT). This technology uses advanced 3D cameras to track surface data, for more guidance across every step of the radiotherapy workflow.

Our SGRT solutions are used in 24 out of the 25 “Best Hospitals for Cancer,” as tracked by US News & World Report.

We’re one of Britain’s fastest-growing private tech companies, as recently recognised by the 2025 Sunday Times 100 Tech list. We’re also the proud winners of a 2024 King’s Award for Enterprise, the UK’s most prestigious accolade for business excellence.

Company video

With around 300 employees globally, and offices in the UK, Poland & the USA, Vision RT operates independently as part of the Danish company William Demant Invest A/S - one of the world’s largest investors in healthcare companies. Vision RT staff members have the security and reach that comes with being part of a large global enterprise, combined with the freedom and agility of a startup.

This is a company with strong values, a clear mission and a bright future. It’s an exciting and rewarding place to work.

About the Role:

We are seeking a dedicated Senior Risk Management Specialist to join our Compliance team. In this role, you will be responsible for creating and maintaining Risk Management Files for Vision RT medical devices, ensuring comprehensive pre- and post-market risk analysis in an agile environment.

This position offers remote flexibility based on experience. Candidates who meet all skill requirements may work remotely, with an expectation of 2-3 days per month at our London or Basingstoke office, particularly during the early stages of the contract.

For candidates who may need to develop certain skills, we offer a hybrid work model, requiring regular in-office collaboration in London or Basingstoke to support learning and development.

Key Responsibilities will include:

Assist in the creation and maintenance of Risk Management files for Vision RT medical devices per, including: Risk Management Plans, Risk Hazard Analysis, Register or Risks, Risk-benefit Analysis, Risk-traceability Analysis, Anomalies/Change Control Review and Risk Management Reports

Participate in risk reviews for proposed design changes.

Create risk control requirements as inputs to product design.

Participate in anomaly review meetings to consider and assign severity scores to known product anomalies.

Conduct risk reviews of post-market surveillance data.

Other duties in support of the company’s quality policy and objectives.

This role requires occasional UK and international travel.

Essential Skills & Experience

Extensive commercial experience in risk management for medical devices

Extensive knowledge of ISO 14971 and ISO/TR 24971.

Extensive knowledge of IEC 62304 and ideally IEC 60601 as well

Working knowledge of application lifecycle management tools used in medical device development.

Strong organizational skills, and ability to triage and prioritise tasks.

Excellent verbal communication, writing and presentation skills.

Ability to work and interact effectively and professionally with others throughout various levels of the global organization.

Competent in Microsoft Word, Excel, PowerPoint, Outlook and general computer usage.

Fluent in written and spoken English.

Desirable Skills & Experience

Working knowledge of IEC 62366-1, IEC 62368-1, IEC 60601-1-2.

Development tools like Polarion, MatrixALM, DOORS, etc

Working in an agile environment

Vision RT is an Equal Opportunity / Affirmative Action employer, all qualified applicants will receive consideration for employment and development without regard to race, colour, religion, sexual orientation, gender, national origin, disability, or protected veteran status.

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