Sinclair is seeking a Risk Manager to contribute to the Global Regulatory Team, ensuring compliance with regulatory submission and launch timelines for medical devices and aesthetic products. In this role, you will maintain risk management activities for legacy devices and support risk processes for new product development. You will work closely with cross-functional teams to enhance risk management practices, ensuring alignment with global regulatory standards and internal policies. This position offers a unique opportunity to drive improvements in risk management, contributing to the successful launch and lifecycle management of our products.
Location: Lakeside, Chester Business Park, Cheshire, CH4 9QT.
About Sinclair
Founded in 1971, Sinclair is a global medical aesthetics organisation, that delivers an extensive product range. With an in-house commercial infrastructure, including manufacturing and a network of distributors in leading global markets, our products are sold in 55 countries worldwide.
This is a great time to join Sinclair as we continue to increase our product range and expand into new markets and territories.
Our Vision
Providing aesthetic excellence globally.
Our Mission
Driving the advancement of product quality and customer satisfaction, investing in innovation and people.
Our Values
- Act with Integrity
- Be results driven
- Embrace your winning spirit
- Stay ahead of the game
- One team, one goal
Roles and 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.
Essential:
- 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 62366-1
- 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