• Job Description

  Req#: 28879

  At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

  We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

  Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

  Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

  For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

  SUMMARY OF POSITION :

  Under the direction of the Group Medical Device Quality Manager, this position is responsible for the strategic oversight of the Cincinnati Quality Management System and the Quality Department, having major impact on Quality performance and the company's ability to market products in accordance with US and international regulations. This position also serves as the official Liebel-Flarsheim Person Responsible for Regulatory Compliance (PRRC) as defined in the article 15 of EU Regulation 2017/745 and Management Representative according to regulatory requirements.

  ESSENTIAL FUNCTIONS :

  • Provide leadership and direction to the Cincinnati Site’s Quality Department, ensuring compliance with all applicable regulations, standards, and QMS procedures.
  • Serve as the Liebel-Flarsheim Site Management Representative per 21 CFR 820 and ISO 13485:2016 requirements.
  • With corporate appointment, serve as the official Liebel-Flarsheim Person Responsible for Regulatory Compliance (PRRC).
  • Serve as the Liebel-Flarsheim Cincinnati Official Correspondent for the US FDA.
  • Drive measurable quality improvements in support of the business.

  PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Establish and maintain Cincinnati facility site quality policy and objectives.
  • Apply best practices, principles, and processes for quality control to all site activities and functions.
  • Responsible for site quality system compliance with government agencies, notified bodies, and third-party certification bodies.
  • Responsible for compliance to government quality regulations, including but not limited to, 21 CFR 820, 21 CFR 11, EU Regulation 2017/745 (EU MDR), ANVISA (Brazil) Guidelines, ARGMD (Australia), Japanese MDR, and Canadian MDR.
  • Direct site activities to evaluate, analyze, and report on product development, product, and process quality performance.
  • Establish and operate site product complaint, field correction, and recall system.
  • Responsible to systematic review and maintain site Quality System components in accordance with corporate policies, procedures, applicable government regulations, and third-party requirements.
  • Responsible for supplier quality audit program to support supplier development initiatives.
  • Manage and direct the internal audit program to maintain compliance with site and regulatory requirements.
  • Responsible for maintaining the site CAPA (corrective and preventive action) program.
  • Responsible for cGMP (Current Good Manufacturing Practices) training and compliance at the Cincinnati facility.
  • Provide a systematic review process and resources to assure all products meet regulatory and conformance requirements prior to market release.
  • Maintain an effective change management system for manufacturing and R&D processes.
  • Responsible for Quality support of new product development process.
  • Lead in the application of appropriate statistically based tools to assess process and product capability.
  • Systematically assess and report quality system performance against internal and external standards.
  • Assure product development, manufacturing and control systems meet the requirements of product technical files.
  • Ensure verification and validation activities are performed as required for design and manufacturing.
  • To be the Person Responsible for Regulatory Compliance (PRRC) as defined in the article 15 of EU Regulation 2017/745 and to be responsible for ensuring that:
    • The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released,
    • The technical documentation and the EU declaration of conformity are drawn up and kept up to date,
    • The post-market surveillance obligations are complied with,
    • The reporting obligations related to serious incidents, field safety corrective actions, trend reporting, and analysis of vigilance data are fulfilled,
    • In case of investigational devices, a statement is issued confirming that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regards to those aspects, every precaution has been taken to protect the health and safety of the subject. This statement is signed by the natural or legal person responsible for the manufacture of the investigational device.
  • As the Cincinnati Site’s Person Responsible for Regulatory Compliance (PRRC), this position has authority to make final decisions on:
    • Product Release (including release of investigational devices),
    • Technical Documentation and Declaration of Conformity release,
    • Post-Market Surveillance,
    • Reporting to authorities.
  • Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
  • Perform other duties and special assignments at this or other divisions of Guerbet, as needed.

  KNOWLEDGE, SKILLS AND ABILITIES:

  • Bachelor’s degree in a STEM field (Science, Technology, Engineering & Mathematics). MBA or master’s degree in a STEM field preferred.
  • Minimum of seven (7) years of experience in regulated quality systems for manufacturing environments. Ten (10) years or more of experience preferred.
  • Minimum of five (5) years of quality management experience. Seven (7) years or more of experience preferred.
  • In-depth knowledge of FDA regulations (21 CFR Part 11, 21 CFR Part 820, etc.), EU MDD/MDR, ISO 13485:2016 and MDSAP.
  • Professional certification, such as ASQ CMQ-OE, CSSGB, CSSBB, CQA, CRE, and/or CQE preferred.
  • Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint, & Visio) and Minitab.
  • As PRRC, per article 15 of EU Regulation 2017/745, any employee holding this position shall possess the requisite expertise in the field of medical devices, as demonstrated by either of the following qualifications:
    • A diploma, certificate, or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline; AND,
    • At least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices.
    • OR, four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

  Reason to join US

  Much more than a Competitive salary,

  
  We offer continued personal development. When you join Guerbet, you :

  • Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
  • Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
  • Are joining a company where we value diversity of talents coming from various horizon.

  We # Innovate # Cooperate # Care #Achieve at Guerbet.

  Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

  Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com or you can also call this number +19843443717

• About the company

  We are a global leader in medical imaging with products and solutions for diagnostic and interventional radiology.

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