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

 

WHAT WE ARE LOOKING FOR

With the Cincinnati Site PRRC’s appointment, this position is designated as an Interim/Deputy Person Responsible for Regulatory Compliance (iPRRC) as defined in the article 15 of EU Regulation 2017/745.

 

Under the direction of the Site Quality Manager, this position is responsible for providing Quality Operations support to various departments within the site, having major impact on Quality performance and the company's ability to market products in accordance with US and international regulations. This position is also responsible for leading the site’s Quality Engineering team supporting manufacturing, product complaint management, distribution center operations, and other critical Quality functions.

 

YOUR ROLE

• By appointment, act as the Interim/Deputy Person Responsible for Regulatory Compliance (iPRRC) per European Medical Device Regulation.

• Provide daily leadership and direction to the Quality Operations team, ensuring that site operations comply with all applicable regulations, standards, and QMS procedures.

• Drive measurable quality improvements in support of operations.

• Manage quality support for operations including device history record and batch release processes.

• Assist various functions as a technical liaison for internal or external Quality matters.

• Using Quality Engineering principles, perform statistical analysis and trending of Quality data to proactively identify opportunities and implement System improvements.

• Perform regular reviews and annual reviews of employees under direct supervision. Provide performance feedback to employees, and coach as needed to foster employee improvement.

• Ensure that Quality Operations employees are qualified and trained to perform their respective job functions, as required by ISO 13485:2016 and medical device regulations.

 

YOUR BACKGROUND

• 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.

• Minimum of two (2) years of quality managerial/supervisory experience.

• Experience in the creation and implementation of SOPs and Work Instructions.

• 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 CSSGB, CSSBB, CQA, CRE, and/or CQE preferred.

• Proficient in the use of Microsoft Office (Word, Excel, Access, PowerPoint, & Visio) and Minitab.

• As Interim/Deputy 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.

 

• Seek out and apply best quality assurance methods and practices in support of Quality objectives.

• Develop, implement, and review procedures and work instructions to