Our client a Global Healthcare organization who is focused on the design, development and commercialization of a diverse portfolio of device technology solutions are currently seeking a Risk Manager to join their team. The Risk Manager at the user interface is a key element in the development of products and Risk Manager will be vital to the development program from concept through to regulatory submission and product lifecycle management.


Role/Responsibility

• At the beginning of a development program, your role will be to develop an understanding of the proposed product, its marketed comparators, and the potential risks associated with design, manufacture and use of the product.
• Your research will contribute to the Device Design and Development and Risk Management Plans.
• You will work within program teams to develop the user- and design-related Design Inputs and drive preliminary Risk Assessments.
• Your research will enable you to collaborate with Device Development colleagues, Clinicians and Pharmacovigilance teams to analyse, evaluate, mitigate and control risks at the user interface in line with international standards and our Quality Management System.
• The role will involve accountability for ownership and enhancement of risk management principles and processes across the group and for working with device program teams to ensure risk management is at the core of all device development activities from design and concept development, through engineering scale-up and industrialization; integrated with both the product and user needs. This will also include authoring content for regulatory submissions and reporting the culmination of the device risk management program through the final risk benefit analysis and support for device lifecycle management upon commercialization.
• The role will require the establishment of Risk Management Plans with the Device Program Teams, and support of design, user, system and process needs across programs and across all GDD functional groups.
• The Risk Manager will be monitoring, investigating and reporting through the risk management program design outputs such as formative usability outcomes and clinical complaints. You will be closely monitoring the competitor landscape and will provide a regular review of medical device reports and product recalls.
• We are looking for a candidate who has a passion for Risk Management in the pharmaceutical and / or medical device industries with experience of the application of FDA and EU regulations and international standards related to risk management. Who is interested in maintaining an awareness of the device development landscape and who has the technical drive and confidence to deliver wide ranging risk management considerations to Mylan’s Global Device Development group.

• Degree in Engineering/Biomedical Science, or equivalent, experience within a pharmaceutical/medical device environment
• Sound problem solving abilities
• Excellent verbal and written communicator; Clear and concise in communications with External and Internal partners with the ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals & established timelines. Demonstrated excellent technical report writing skills.
• Experience of Risk Management in Medical Device or Pharmaceutical Industry
• Experienced in ISO and FDA regulations and standards as applicable to risk management.
• A strong team player willing to support any other organizational needs/activities outside primary expertise to continuously enhance the Global Device Development group.
• Willing to take on and support other activities outside core expertise as required to develop the future of the department