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Risk Management Specialist
2 months ago
We are seeking a highly skilled Risk Management Specialist to join our Global Regulatory Team at Sinclair. As a key member of our team, you will play a critical role in ensuring compliance with regulatory submission and launch timelines for medical devices and aesthetic products.
Key Responsibilities:
- Lead and coordinate all risk management activities according to ISO 14971 standards.
- Plan, prepare, and perform risk management for medical devices and aesthetic products according to project phases, adhering to internal procedures and external regulatory requirements.
- Represent Risk Management on assigned development projects.
- Establish risk acceptance criteria for individual residual risks and overall residual risks for both development and legacy devices.
- Maintain a close link to the Human Factors/Usability Engineering process to ensure user and patient safety.
- Support the creation of device design specifications to ensure appropriate risk control measures.
- Monitor the implementation, verification, and validation of risk control measures.
- Stay updated on company policies, standards, guidelines, industry practices, and relevant regulatory requirements.
- Ensure a harmonized approach to risk management across projects and facilitate communication with the R&D team to share lessons learned.
- Ensure risk management processes integrate data from Design Authorities, including Design FMEAs, Security Risk Analysis, and Human Factors evaluations.
- Prepare risk management reports in a timely manner, compliant with ISO 14971, company SOPs, and guidelines, ensuring adequacy for regulatory inspections and audits.
- Present project-specific risk management activities during regulatory body inspections and internal audits.
- Collaborate cross-functionally with Global Marketing, Regulatory Affairs, Clinical Affairs, and Manufacturing teams.
- Support the integration of risk management between development and post-market product phases.
- Ensure identification, estimation, and evaluation of hazards associated with the product portfolio, and monitor the implementation, verification, and validation of risk controls.
- Assure that company quality standards and applicable government regulations are met through independent risk management of medical devices.
- Perform risk management for medical device and aesthetic projects, assisting sites in ensuring timely and detailed risk management for new device introductions and regulatory inspections.
- Take overall responsibility for ensuring medical devices and aesthetic products are safe, effective, and compliant with global regulations.
Requirements:
- Minimum of 5 years of experience in the regulated medical device industry
- Knowledge of usability engineering or human factors engineering for medical devices
- Proficiency in risk assessment methods
- Specific knowledge of active medical devices
- Experience with the Medical Device Regulation (MDR)
Desirable:
- Bachelor's degree
- Experience in the manufacture of medical devices
- Good knowledge of medical standards, such as:
- ISO 14971:2019
- ISO 13485:2016
- IEC
- IEC 62304
- 21 CFR 820
- (EU) 2022/2346
Role Competencies:
- Experience in performing risk management for medical devices
- General understanding of potential sources of risk and strategies for management
- Flexible approach with the ability to adapt to changing circumstances and priorities
- Highly self-motivated, goal-oriented, and proactive, with the ability to meet deadlines and complete projects
- Excellent communication and presentation skills, both verbal and written, to inform and persuade effectively
General Competencies:
- Strong team player, decision maker, and problem-solver
- Patient, understanding, and empathetic
- High level of attention to detail
- Strong interpersonal skills and sensitivity
Benefits:
- 25 days annual leave (plus bank holidays)
- Bonus based on performance
- Free parking
- Opportunities for development and progression
- Company pension scheme
- Private medical insurance
- Healthcare Cash plan
- Health Screening
- Employee Assistance Programme
- Store discounts
- Tech and Cycle Scheme
- Discounted dining card
- Cycle to work scheme
- Green car scheme
- Holiday buy and sell
- Life Assurance scheme
