Risk Manager

Sinclair; Monza; On-site; EUR 60,000 - 90,000; Full time

Job summary

Sinclair is seeking a Risk Manager to lead risk management activities for legacy devices and new product development in the medical aesthetics field.

You will ensure compliance with ISO 14971, ISO 13485, MDR, and related internal procedures, while coordinating with R&D, regulatory, and manufacturing teams to manage risk across projects.

Qualifications

• Minimum of 2 years of experience in regulated medical device industry.
• Knowledge of usability engineering or human factors engineering for medical devices.
• Knowledge in usage of risk assessment methods.
• English: Fluent

Responsibilities

• Lead and coordinate risk management activities according to ISO 14971, ISO 13485, MDR and annex XVI.
• Plan, prepare and perform risk management for medical devices and aesthetic products.
• Represent Risk Management on assigned development projects.
• Establish risk acceptance criteria for residual risks and overall residual risk.
• Maintain link to Human Factors/Usability Engineering process to ensure user safety.
• Monitor that risk controls are implemented, verified and validated.
• Ensure harmonized approaches to risk management across projects.
• Prepare risk management reports for regulatory inspections and audits.

Skills

Regulated medical device experience

Usability engineering

Risk assessment methods

English fluency

Education

Master's degree in Engineering (Materials, Biomaterials, Chemistry, Biochemistry, Biology)

Job description

Sinclair is Hiring! Join Our Team as a Risk Manager. We are currently recruiting for Risk Manager. The Risk Manager will have reports into the R&D Director to contribute directly to meeting regulatory submission, launch timelines of medical devices and aesthetic products as well as regular review activities.

The Risk Manager is responsible to maintain risk management activities for legacy devices and to support new product development activities.

The Ideal Candidate Will Have

• Minimum of 2 years of experience in regulated medical device industry
• Knowledge of usability engineering or human factors engineering for medical devices
• Knowledge in usage of risk assessment methods
• Masters Degree of Engineering degree in the following fields or equivalent (Materials, Biomaterials, Chemistry, Biochemistry, Biology)
• English: Fluent

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.

Sinclair Values: Act with Integrity Consistently doing the right thing even when it’s the hard choice; 100% Compliance with all rules, standard operating procedures and guidelines; Results-Driven Make a business impact in all you do, whether sales, efficiency, operational excellence; it should make a meaningful impact; Innovation-Centered Redefining Aesthetics, we must be pioneering in how we do business; this can be in products, in service models, or strategy; Own It! Be Accountable for your decisions, actions and consequences; Be Reliable to your customers and colleagues

What You'll Be Doing

• Lead and coordinate all risk management activities according to ISO 14971, ISO 13485, MDR and annex XVI.
• Plan, prepare and perform risk management for medical devices and aesthetic products according to project phases following all relevant internal procedures, processes, and external requirements for development products.
• Represent Risk Management on assigned development projects.
• Establish risk acceptance criteria for individual residual risks and the overall residual risk for specific devices in development and for legacy devices
• Maintain a close link to the Human Factors / Usability Engineering process to meet the needs and ensure the safety of all users and patients.
• Support creation of device design specifications to ensure that risk control measures are appropriate.
• Monitor that risk control measures have been implemented, verified, and validated.
• Maintain knowledge of current Company policies, standards and guidelines as well as industry practices, regulatory requirements, and other relevant information.
• Ensure harmonized approaches to risk management across projects. Communicate with Research and Development team members on other projects to share lessons learned and ensure use of common tools and ideas within the team.
• Ensure that the risk management process incorporates all relevant data from the Design Authorities e.g., Design FMEAs, Security Risk Analysis, Use-related risk analysis, formative human factors evaluations and human factors validation studies.
• Ensure that risk management reports are prepared in a timely manner and in accordance with ISO 14971 and applicable Company SOPs and guidelines and are adequate for inspection by notified bodies and other relevant authorities.
• Present project-specific risk management activities at regulatory body inspections and internal audits.
• Work cross-functionally with other global functions: e.g., Global Marketing, Global Regulatory Affairs, Clinical Affairs and Manufacturing.
• Support a good link between risk management during development and risk management for marketed products.
• Ensure that all hazards associated with a medical device and aesthetic products are identified, the associated risks are estimated and evaluated and that these risks are controlled; monitors that these risk controls are implemented, verified and validated.
• Assures that Company quality and compliance standards and applicable government regulations are met by means of independent risk management for medical devices under development.
• Performs risk management in medical device and aesthetic projects and assists medical device sites in ensuring that risk management is performed in sufficient detail and in a timely manner for new device introductions and regulatory agency inspections.
• Has overall responsibility that medical devices and aesthetic products are designed to be safe, effective and in compliance with the applicable regulations worldwide.

Your Skills And Experience Essential

• Minimum of 2 years of experience in regulated medical device industry
• Knowledge of usability engineering or human factors engineering for medical devices
• Knowledge in usage of risk assessment methods
• Masters Degree of Engineering degree in the following fields or equivalent (Materials, Biomaterials, Chemistry, Biochemistry, Biology)
• English: Fluent

Desirable

• Experience in the manufacture of Medical Devices
• Good knowledge of medical standards, e.g.:
• ISO 14971:2019
• ISO 13485:2016
• MDR
• Annex XVI (MDR)

What We're Looking For:

• Experience in performing risk management for medical devices
• A general understanding of the potential sources of risk and how to manage
• Flexibility in approach and ability to adapt to changing circumstances and priorities when required
• Highly self-responsible, goal-oriented and proactive, with ability to complete projects and meet deadlines
• Excellent communication and presentation skills, to inform and persuade both in speaking and in writing

General Competencies

Excellent team player, decision maker and problem-solver

• Patient and understanding
• High level of attention to detail
• Strong interpersonal skills and sensitivity
• Empathetic

  The company is full of opportunity for those who wish to grasp it. Our people thrive on engagement, development and a varied workload. You will often be included in projects that require you to collaborate cross-functionally.

  This is an exciting opportunity to join a successful company, with big ambitions for the future.

  Please note if we receive a high volume of applications, we may close the role before the closing date noted.

  Sinclair does not accept speculative or unsolicited CVs from Recruitment Agencies.

  Any unsolicited CVs received will be treated as property of Sinclair and Terms & Conditions associated with the use of such CVs will be considered null and void