Offers “Sanofi”

Expires soon Sanofi

Risk Management Engineer (Risk Manager)

  • Cambridge (Cambridgeshire)
  • Teaching

Job description

POSITION OVERVIEW

The Risk Manager works embedded in one or more device development teams. The position contributes directly to meeting regulatory submission and launch timelines of the medical devices and combination products in development specifically in relation to safety and cybersecurity risk management needs.

DUTIES & RESPONSIBILITIES:

Primary Responsibilities:

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Ensures that all hazards, threats and vulnerabilities associated with a medical device 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.

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Assures that Sanofi quality and compliance standards and applicable government regulations are met by means of independent risk management for medical devices under development.

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Performs risk management in medical device 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.

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Has overall responsibility that medical devices are designed to be safe, effective and in compliance with the applicable regulations worldwide.

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Lead all risk management activities according to ISO 14971 and TIR 57.

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Plan, prepare and perform risk management for medical devices according to project phases following all relevant internal procedures, processes and external requirements for development products.

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Maintain a close link to the human factors engineering process to meet the needs and ensure the safety of all users and patients.

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Maintain knowledge of current Sanofi policies, standards and guidelines as well as industry practices, regulatory requirements, and other relevant information.

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Ensure harmonized approaches to risk management across projects. Communicate with RM team members on other projects to share lessons learned and ensure use of common tools and ideas within the team.

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Present project-specific risk management activities at regulatory body inspections and internal audits.

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Work cross-functionally with other global functions e.g., Diabetes Division, Global Marketing, Global Medical Affairs, Corporate and Regulatory, Pharmacovigilance, R&D, Information & Technical Systems

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Support a good link between risk management during development and risk management for marketed products.

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Support process improvement initiatives for both safety and cybersecurity risk management processes

Additional Responsibilities:

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Support Clinical Evaluation & Device Monitoring activities –

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Interact with internal teams (engineering/product development/regulatory) to define the plan and strategy for development of the Clinical evaluation reports for new products requiring CE Mark.

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Manage relationship with clinical evaluation suppliers

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Acquire knowledge of therapeutic areas, competitor devices, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.

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Participate in and/or perform comprehensive literature and global database (e.g. MAUDE) searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies, stay informed about applicable clinical landscapes and trends and known risks.

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Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.

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Managing CER timelines required by product development teams and global Regulatory Bodies by utilizing the appropriate project management tools.

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Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities.

QUALIFICATIONS:

Basic:

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Minimum of bachelor’s degree or equivalent in science or engineering or similar field

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At least 3-5 years relevant experience in risk management for medical devices

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Very good knowledge of and experience in performing safety and cybersecurity risk management for medical devices

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Good knowledge of usability engineering or human factors engineering for medical devices

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Proficient in usage of risk assessment methods, e.g.: Hazard Analysis (PHA), Software Risk Analysis, Fault Tree Analysis (FTA) , Failure Modes and Effects Analysis (FMEA)

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Good knowledge of international medical standards, (e.g.: ISO 14971, ISO 13485, TIR 57, IEC 62304, MDR, ISO/TR 80001, IEC TR 80002-1)

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Knowledge of relevant methods, industry standards and trends within risk management for medical devices

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Strong Analytical Skills

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Demonstrated understanding of information security practices, risk management processes, cybersecurity principles, and incident response methodologies

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Understanding of national and international laws, regulations, and policies related to regulated medical device cybersecurity

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Demonstrated experience interfacing with customers and other external stakeholders regarding cybersecurity system design and behavior

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Fluent in English

Preferred:

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A general understanding of the potential sources of risk and how to manage them

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Flexibility in approach and ability to adapt to changing circumstances when required

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Highly self-responsible, goal-oriented and proactive, with good attention to detail and ability to complete projects and meet deadlines

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Strong interpersonal skills and sensitivity

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Excellent communication and presentation skills, to inform and persuade both in speaking and in writing

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Excellent team player, decision making and problem-solving

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Ability to learn quickly and self-educate on different technologies/therapies as applicable to medical products and procedures (Self-starter attitude)

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Demonstrated ability to develop and grow productive, trusting, and open relationships with a wide variety of constituencies. 

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Demonstrated ability to build a product security team supporting pre and post market products

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Wireless communication systems knowledge and experience

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Expertise in Agile and can work with at least one of the common frameworks

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The ideal applicant will have experience in at least one or more of the following technical domains:

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Medical devices and systems

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IoT (embedded) devices and systems

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Cloud systems architecture and security

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Large-scale application architecture and security

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Mobile device application architecture and security

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Data protection architectures for data at rest and in transit

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Risk assessments and cybersecurity regulatory requirements

· 
Programming experience (e.g. SQL, VBA)

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

#GD-SA

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

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