Why Prism Healthcare

We are providers of specialist moving, handling and bathing equipment for elderly, disabled and mobility disadvantaged clients in a range of care environments, from community care to schools, hospitals and care homes. Employing employing circa 700 colleagues, across various locations within the UK and Europe, we work with a variety of mobility equipment, including patient moving, handling, and bathing devices, committing to the ongoing safety and wellbeing of the people who use our equipment. Through our family of brands, we are best positioned to share our experience and expertise with every client and customer.

With over 30 years of experience in designing, developing, manufacturing, providing and installing bespoke mobility and care solutions, we have an established track record of working closely with carers and their clients across the UK.  The Group has grown over the last year both organically and by acquisition, with a turnover of £100M.

Role Description

The Group Regulatory Affairs Lead is responsible for ensuring that all new and existing products and services across the Prism Healthcare Group meet applicable regulatory and safety requirements in all target markets.

This role will provide regulatory oversight across multiple sites with a focus on Class I medical devices (approx. 95% of the portfolio) including hoists, assistive devices, and specialist furniture.

The successful candidate will act as the group’s regulatory subject matter expert, guiding teams on standards, risk management, technical documentation, and product safety, while rationalising and maintaining technical files.

This role will be a Hybrid based role, with the successful candidate able to travel to various Prism Healthcare locations in the UK on a frequent basis.

Essential Duties

• Own and manage all Regulatory Affairs activities across the Prism Group sites, ensuring ongoing compliance with MDR, UKCA, and other applicable regulatory frameworks.
• Maintain and develop technical documentation for both new and existing products.
• Participate actively in all NPD and design review meetings, providing regulatory guidance at each stage of product development.  Support design and development documentation from a QA/RA perspective, reviewing risk files, change controls, and ensuring new designs meet safety and compliance requirements.
• Interpret standards, assess compliance gaps, and justify conformity through robust risk and hazard evaluation.  Advise on the application of product safety and performance standards (e.g., fire safety, electrical safety, IEC 60601).
• Support teams in defining and justifying appropriate test plans for new and modified products.
  Ensure testing activities align with relevant ISO and IEC standards, maintaining a clear rationale within technical documentation.
• Advise on export requirements and submission strategies for new and existing markets.  Serve as lead contact for registered European and overseas importers as required.
• Support internal and external audits and provide training sessions to raise regulatory awareness across sites.  Support the Group QMS manager in the attainment and retention of key organisational quality accreditation.
• Work with training to ensure that the commercial & operational organisations are ‘knowledge enabled’ to a standard level of competency for client/customer activities.

Personal Characteristics/Education & Experience

• High attention to detail and follow through.
• Evolved and mature project management skills
• Proactive, relationship oriented, and results driven.
• Comfortable in navigating uncertainty and managing resistance to change.
• Performs well against deadlines.
• Demonstrates customer centric behavior, empathy & care.
• Demonstrates cultural sensitivity.
• Exceptional listening skills.
• Personifies Prism Healthcare, Mission, Vision and Values.
• Team player
• 5-10 years’ regulatory experience in medical device design & manufacture, minimum Class I, Class IIA would be advantageous.
• Experience of working in a manufacturing environment in accordance with the requirements of ISO 13485, ISO 9001, ISO 14001 & the EU Medical Device Directive/ Medical Device Regulations.
• Experience taking medical devices into new overseas markets.
• Conversant with EU, APAC and US, and other global regulations; ideally, they will have experience of submitting medical device applications to the notified bodies in the mentioned regions.
• 5-10 years healthcare experience.
• 1st or 2nd Degree supported by relevant professional affiliations / accreditations.
• Strong interpersonal, influencing and relationship building skills.
• Proficient in Microsoft Office applications including Adobe Acrobat, Word, Excel and PowerPoint.
• Demonstrate effective time management skills, administrative capabilities, and effective written and oral communication capabilities.
• Flexible approach to work and working hours.
• Current clean driving licence

So.. why us?

Alongside working in a supportive and friendly environment, you’ll also receive:

• Competitive Salary, paid monthly
• Ongoing training and development
• 25 days holiday, plus bank holidays
• Pension Scheme, matched contribution/salary sacrifice
• Medicash health Plan which allows you to claim towards health costs such as dental and optical as well as physiotherapy and chiropody
• Life Assurance Scheme
• Long Service Awards
• Holiday Purchase Scheme

Why Prism Healthcare

We are providers of specialist moving, handling and bathing equipment for elderly, disabled and mobility disadvantaged clients in a range of care environments, from community care to schools, hospitals and care homes. Employing employing circa 700 colleagues, across various locations within the UK and Europe, we work with a variety of mobility equipment, including patient moving, handling, and bathing devices, committing to the ongoing safety and wellbeing of the people who use our equipment. Through our family of brands, we are best positioned to share our experience and expertise with every client and customer.

With over 30 years of experience in designing, developing, manufacturing, providing and installing bespoke mobility and care solutions, we have an established track record of working closely with carers and their clients across the UK.  The Group has grown over the last year both organically and by acquisition, with a turnover of £100M.

Role Description

We are seeking a skilled and motivated individual to join our team as a QHSE Manager, working within operations this role will work with all areas of the manufacturing team in ensuring a good health & safety culture is built and maintained throughout the business and be responsible for deploying Prism Medical’s quality management system. Driving updates and changes to the system and ensuring all department managers understand requirements. I.e. quality failures analysis, cost of poor quality etc.

Essential Duties

• Lead driving a culture of health & safety and quality across both manufacturing sites.
• Effectively lead and deploy the quality team (x4) to achieve quality KPI targets.
• Reporting of accidents and incidents and supporting staff in carrying out accident investigations.
• Ensure the business QMS is up to date and being followed by departments.
• Key contact for customer and external body complaints and assisting / directing operations staff in their investigations.
• Carrying out toolbox talks and give guidance and direction on health & safety and quality related matters.
• Guiding department heads to help build health & safety awareness within their departments.
• Liaise with suppliers on ongoing performance and resolution of supplier quality issues.
• Create reports on site health & safety, quality & environmental performance, for review at senior management and board level.
• Support operations director in monitoring and driving improvements to achieve health & safety, quality & environmental KPIs.
• Work with operations staff to carry out health and safety risk assessments of onsite processes.
• Work as part of the team producing FMEAs, risk management plans and risk management reports.
• Liaise with group compliance staff to ensure all product regulatory requirements are met.
• Lead the internal auditing team for all manufacturing sites and ensure completion of the audit schedule.
• Liaise with suppliers on PPAP requirements and new product introduction.
• Support operations teams in creation of SOPs.
• Support in producing company literature (instructions for use etc.).
• Liaise with R&D department in the testing of new products.

Personal Characteristics

• High attention to detail and follow through.
• Proactive, relationship oriented and results driven.
• Hands on, “can do” approach with the ability to understand the true issues and identify root causes of problems.
• Comfortable in navigating uncertainty and managing resistance to change.
• Performs well against deadlines.
• Confidence to challenge people’s behaviour.
• Demonstrates customer centric behaviour, empathy & care.
• Demonstrates cultural sensitivity.
• Exceptional listening skills.
• Team Player.

Education & Experience

• Minimum of 5 years’ health & safety, quality & QMS experience required.
• Experience of working in accordance with the requirements of ISO 9001 (ISO13485 & ISO 14001 would be desirable)
• Excellent quality systems knowledge Internal auditing qualified (minimum ISO 9001)
• Experience within Manufacturing
• NEBOSH or IOSH qualified
• Experience working in a HSE responsible role, liaising with suppliers on complaints and PPAP submissions, experience of implementation of QMS within a business and problem-solving techniques. (8D, 5 Whys, Ishikawa etc.)

This role is predominately based at Rhyl, with monthly travel to our site in Bridgend.

So.. why us?

Alongside working in a supportive and friendly environment, you’ll also receive:

• Competitive Salary, paid monthly
• Ongoing training and development
• 25 days holiday, plus bank holidays
• Pension Scheme, matched contribution/salary sacrifice
• Medicash health Plan which allows you to claim towards health costs such as dental and optical as well as physiotherapy and chiropody
• Life Assurance Scheme
• Long Service Awards
• Holiday Purchase Scheme