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Risk Management Specialist

2 months ago

Chester, Cheshire, United Kingdom Sinclair Full time
Job Title: Banking RISK MANAGER

Sinclair is seeking a highly skilled Risk Manager to join our Global Regulatory Team. As a key member of our team, you will play a crucial 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.
  • 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.
  • 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)

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