Descripción de la oferta
OverviewSinclair is Hiring! Join Our Team as a Risk ManagerWe 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.ResponsibilitiesLead 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.Present project-specific risk management activities at regulatory body inspections and internal audits.Your skills and experienceEssential: Minimum of 2 years of experience in regulated medical device industryKnowledge of usability engineering or human factors engineering for medical devicesKnowledge in usage of risk assessment methodsMasters Degree of Engineering degree in the following fields or equivalent (Materials, Biomaterials, Chemistry, Biochemistry, Biology)English: FluentDesirableExperience in the manufacture of Medical DevicesGood knowledge of medical standards, e.g.: ISO 14971:2019, ISO 13485:2016, MDR, Annex XVI (MDR)What We\'re Looking ForRole competencies: 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 writingGeneral competencies: Excellent team player, decision maker and problem-solver; Patient and understanding; High level of attention to detail; Strong interpersonal skills and sensitivity; EmpatheticThe 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. If this sounds like you and you meet the requirements, please apply, we would love to hear from you.Please note if we receive a high volume of applications, we may close the role before the closing date noted. By making this application you give consent for personal information to be used in automated decision-making processes relating to key job requirements which are stated in this ad. 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
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