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Medical Device Specialist
4 months ago
**Job Title**: Medical Device Specialist
**Location**:Burgess Hill - All options of fully office based, hybrid working or fully remote
**Salary**:£35-£45 per hour Ltd/UMV or £26.10-£33.56 PAYE basic pay (excluding holiday)
**Full Time**
**6 month contract**
Our client based in Burgess Hill is looking to recruit a Medical Device Specialist within the Safety Operations. The team uses their high level safety and vigilance expertise, to ensure safety data is processed and reported in a high quality, compliant manner,so it can be used to understand and communicate the product benefit risk to protect patients' safety.
They focus on mindset, where they want you to see beyond a job title and consider where you can have the biggest impact on patient safety. This jobholder is accountable for delivering the strategy for the transformation and delivery of medical device safetydata in order to meet both current and future requirements for a variety of safety related data outputs. The jobholder will play a key role in the design and implementation of medical device processes, and will be accountable and responsible for training andupskilling for the rest of the PDSO organisation.
Your will be responsible for oversight of the processing and reporting of device related safety incidents at our service provider via the utilisation of current/future safety systems, and partners to ensure that the quality/usability of AEs and other safetyreport outputs conforms with agreed customer requirements (e.g., regulatory compliance requirements described via processes; and/or internal scientific data requirements).
**Requirements**:
- Profound knowledge and expertise for medical device reporting processes, partnering with other safety functions to meet both current and future requirements for a variety of safety related data outputs and HA communications
- Accountable leader, who role models proactive, self-motivated process development and issue management and supports the development, maintenance, and review of metrics and KPIs to identify opportunities for continuous improvement
- Quality mindset, maintains procedural documents and training, devises strategies and solutions to contain issues, mitigate risks and develop solutions, is transparent with risks identified and escalates to safety network where necessary.
- Effective oversight of service providers via relationship management, metrics and analysis. Monitors workload, compliance, and quality across the medical device data global footprint to ensure internal and external performance standards are maintained
- Highly skilled at communicating expertise in a rational and structured approach to upskill colleagues, and to articulate the process and approach to external stakeholders e.g., during regulatory inspections
- Independent decision-maker, making compliant and pragmatic decisions based on seeing
- Critical thinker who can see the bigger picture in order to connect processes, data, ideas, and people. Sustaining effective partnerships with key stakeholders across Safety functions and the wider organisation to ensure success of Operations related activities.
- Self-motivated to learn about new data sources, new regulations, and seek to co-create new solutions when required e.g., learning about novel artificial intelligence tools to develop new approaches with 'humans in the loop'
- Effective leadership of complex initiatives with multiple stakeholders, with the ability to investigate and creatively solve problems and simplify, whilst meeting customer needs.
- Developing and maintaining knowledge of the use of relevant new methods and technologies (e.g., artificial intelligence) for safety data processing.
- Team worker and coach, who acts on behalf of the whole company, and is open and supportive in co-located and virtual, matrix teams.
- Adaptable with the ability to handle ambiguity and continuously reprioritise to focus upon the most impactful work to our stakeholders and patients
**Qualifications**:
- Evidence of advanced learning e.g., an undergraduate degree, however on-the-job safety and vigilance experience would be equally considered.
- Significant depth and breath of Medical Device safety and incident reporting, ideally in both pre-and post-marketing setting
- Evidence of leading complex, time-pressured projects, working with a wide range of stakeholders.
For more information, please contact Chloe McCausland at Clearline Recruitment.
