Risk Management Specialist in Woodstock

Owen Mumford are looking to hire a Risk Management Specialist! Could this be your next role?

Scope: As the Risk Management Specialist at Owen Mumford, you will be responsible for providing the overall management and compliance to risk management requirements, including the implementation of risk management files for R&D projects, and the upkeep of existing on-market devices.

Key Responsibilities:

• Subject Matter Expert for risk management and responsible for the associated deliverables during all product lifecycle stages - including facilitating the flow of on market device/medicinal products feedback and Post Market Surveillance output into Risk Management Files.
• Provide Risk Management knowledge and input knowledge of known issues with on-market products in the review and update of Risk Management Files.
• Ensure risk management activities are compliant with Regulatory requirements and ensure the process continues to meet those requirements.
• Preparation and maintenance of Risk Management documentation and support of new development risk management activities, working with R&D/CI/Human Factors, and Production/Industrialisation teams where required.
• Supporting any required amendments to risk management documentation as requested by R&D/CI/Human Factors, Production/Industrialisation teams and the Regulatory Affairs Manager, as required.
• Responsible for facilitating the review, update and amendments to all affected risk management documentation associated with user, design and process changes, complaints, adverse events, recalls, regulatory updates or other feedback from the post market surveillance system.
• Facilitate the review of risk management files - when requested by the Product Safety team - and process amendments to Risk Management Files where required, following complaints and/or recalls on non-OM devices in the market place that are substantially equivalent to those that OM produce.
• Communicate with action owners and/or their Managers to highlight any open actions and facilitate their timely closure.
• Ensure any associated KPIs are reported accurately and within the timescales set.
• Support any other activities as required by the Regulatory Affairs Manager.

To be successful in this role, you will need:

• Experience of Medical Device manufacturing and Quality Management Systems to support the review of Risk Management Files.
• Experience of complaint handling/trending for medical devices and or medicinal product.
• Understanding of Post Market Surveillance requirements for Europe.
• Proficient in the use of Microsoft Excel, Power Point and Word. Experience in technical report writing.
• Understanding of Regulatory Requirements for risk management.

What will we give you?

You will be joining a successful, privately owned industry leader who are constantly innovating and looking to improve lives, empower patients and relieve the pressure on healthcare professionals. We invest heavily in our staff and offer a competitive salary and benefits package along with the opportunity to develop within the business.

Additional benefits include:

• Remote working up to 2 days per week
• Flexi time covering 37.5 hours per week with core working hours of 9:30am-12 Noon and 2:00pm-4:00pm (3:30pm on Fridays)
• 25 days annual leave (with the opportunity to earn loyalty days with length of service)
• Company pension scheme with employer contributions
• Holiday purchase scheme (up to 10 days purchased per holiday year)
• Enhanced Family Friendly Policies
• Enhanced Sickness Pay
• BUPA Cash Plan
• Cycle2Work Scheme
• Electric Car Scheme
• Wellbeing initiatives and support
• Free parking, free tea & coffee

About us:

Owen Mumford is a global leader in medical device design and manufacture. For over 70 years we have been inventing life-enhancing devices that are tested and proven to deliver an industry benchmark in the safety, accuracy and comfort of medication administration. This strong heritage is the springboard for our future as we help to shape the progress of the healthcare industry by bringing pioneering concepts and solutions to life in an accountable and sustainable way. Headquartered in the UK, Owen Mumford is a family-run business with a large global presence across North America, EMEA and APAC.

Owen Mumford is an equal opportunities employer. We aim to ensure that no candidate or employee receives less favourable treatment on the grounds of gender, race, disability, sexual orientation, religion or belief, age, gender identity, marital or civil partnership status, pregnancy or maternity. Every job offer is subject to satisfactory references and compliance with vetting requirements applicable to the job role.