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Field Safety Advisor

2 months ago

United Kingdom The AbedGraham Group Full time

Job Role Overview Clinical Safety Officer - This opening is to join one of the foremost strategy, risk and compliance providers in the UK. We are looking for an experienced Clinical Safety Officer (CSO) to support our growing international client base.

We provide a range of strategic, marketing, project management and compliance services for health IT, security, medical device and network infrastructure vendors. Within our compliance service set, we provide DCB0129, Digital Technology Assessment Criteria (DTAC), Data Security and Protection toolkit (DSPT) and cybersecurity services for dozens of the industry’s leading companies.

The job role is to join the compliance team at The AbedGraham Group in the capacity of Clinical Safety Officer. Within the NHS, all suppliers of digital technologies that impact patient care are obliged to comply with the mandatory DCB0129 standard and complete DTAC submissions for review by purchasing organisations or regulators. The AbedGraham Group assists dozens of companies with these processes and frequently acts as the Clinical Safety Officer on their behalf. You will be working under the COO to help maintain existing clients’ compliance and ensuring new clients’ requirements are met. Our compliance work extends across a huge range of specialties from primary to secondary to community and mental health care and across dozens of healthcare IT verticals including EHR, document management, radiology, psychiatry, remote monitoring, online and video consultations, community testing, speech recognition and digital dictation, genomics and surgery.

An approved Clinical Safety Officer (that is either evidence of NHS Digital’s risk course attendance or a similar accreditation)
At least 2 years’ experience in either creating or reviewing the standard documents within DCB0129 (clinical safety case report, hazard log, clinical risk management plan/system)
Knowledge of ongoing compliance requirements (software testing, release reviews, incident management)
Experience with companies who have Artificial Intelligence (AI) as part of their product set
Knowledge or experience of medical device regulations including ISO13485 and ISO14971
Knowledge of wider DTAC competencies (security, data protection, interoperability)
Experience in or working with NHS Digital or regional/national procurements/rollouts
Experience with medical device regulation

Fully remote working
Competitive Salary
Up to 10% bonus annually
Private healthcare cover
Company pension
All professional training/accreditation requirements and costs covered
Finally the opportunity for job growth is important to us.