Regulatory Affairs Risk Management Specialist

Job Purpose

The Risk Management Specialist will be responsible for all risk management activities at the business (manufacturing and product), ensuring risks are correctly identified and mitigated. The successful Risk Management Specialist will need to have experience and knowledge of ISO14791 in a regulatory / quality assurance environment. Ideally, this person will also have a good knowledge of the medical device market and manufacturing environment.

Risk Management Specialist Requirements:
• In-depth knowledge of ISO14791
• Experience of applying the requirements of risk management and developing complimentary process / procedures.
• Previous work experience within the medical devices industry, ideally on dental devices or rotary tools.
• Ability to analyse designs during development and life-cycle management using state-of-the-art risk management tools & techniques to improve product and process robustness.
• Ability to amend and review various documents relating to product changes, complaints and recalls
• Experience of compiling and maintaining Risk Management Files during development, submission and the product life-cycle.
• Knowledge of risk management requirements, Design Control and Human Factors Engineering.
• Some experience in a quality assurance / regulatory affairs medical devices environment.
• Capable of interacting with internal quality functions, development and operations teams for all risk management related aspects
• You will provide coaching and training to other employees with respect to risk management tool

Key Performance Measures

• Working knowledge of implementation of ISO 14971, keep abreast of new requirements related to risk management
• Contribution of output from risk review for complimentary processes including PMS, Clinical Evaluation, Biological Evaluation, Verification and Validation.
• Compilation and maintenance of all risk management files related to the devices•

Key Responsibilities

• Ensuring complete risk management documentation with responsibility of further developing and implementation ISO 14971 in the internal risk management process for medical devices during their entire life cycle
• Supporting all cross functional teams involved in risk management activities
• Writing and revision of all SOP/Work Instructions/Procedures required to ensure risk management and understood and carried out correctly where appropriate

Decision Making

• Works with minimal supervision, taking personal responsibility for own actions and for the quality and accuracy of the work that is produced
• Uses personal judgement and initiative to develop effective and constructive solutions to challenges and obstacles
• Applies the tools within the relevant risk standards and procedures confidently within their role as specialist

Communication & Contacts

• Builds strong relationship across the wider team to share good practice, updates and learnings
• You will have a strong understanding of the importance of working with a diverse range of stakeholders

People Management

• None

Financial Responsibility

• Contribute to budgeting for your area of the overall departmental budget
• Costing and invoicing of services required to aid you in carrying out your role


• All employees are responsible for the care and safekeeping of all company equipment as appropriate to their role
• Issues requiring training and/or qualification not undertaken/held by the employee must be escalated to the correct person
• Untrained/unqualified employees are forbidden from undertaking the use or maintenance of equipment

Qualifications & Experience

• Scientific or engineering degree with experience in the medical device or pharma industry, preferably in a risk management or quality environment position.
• Strong hands-on background expertise in the application of relevant ISO standards such as ISO 13485, 14971, 62366 and the relevant FDA regulations
• In-depth experience with design history files, technical files and other regulatory submission relevant documentation
• Good communication, presentation and organisational as well as basic project management skills
• Strong analytical, problem solving and project delivery skills with attention to detail
• Ability to prepare technical reports

Personal Qualities

• Passion for quality, delivery, and continuous improvement
• Excellent communication skills to disseminate information verbally and in writing to technical and non-technical people
• Strong analytical, problem solving and project delivery skills with attention to detail
• Proactive, quick learner and capable of working independently
• Effective problem solving skills (Operational Excellence)

• Fluency in written and spoken English
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks, be able to identify problems and work toward solutions.

Working Environment

• This role is office based (with some remote working available)
• The nature of the work requires a willingness to undertake national and international travel and have a flexible approach to working hours

Closing date: 26 November 2021


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