Medical Devices

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.

**Location**: Villepinte (93)

**Responsibilities**:

- Capture, review and analyze product complaints.- Follow-up on customer usage reports and field service reports as necessary.
- Comply with relevant global product quality related guidelines, standards and regulations regarding the receipt, review, investigation, and reporting of product usage experiences. This includes determining if complaints qualify as Medical Device Reports per Global Health Authorities regulations and guidance or if complaints potentially qualify as Vigilance reports per Global Health Authorities regulations. It also includes evaluation of complaints for possible Adverse Events which are then forwarded to pharmacovigilance for review.
- Collaborate with field service and manufacturing site personnel.
- Review completed investigations for complaints and vigilance reports.
- Collaborate with colleagues on reporting to regulatory bodies for imaging drug products and devices.
- Conduct trend analyses in order to provide an alert to changing safety profiles on regular and adhoc basis.
- Prepare and deliver accurate reports of continuing product performance for use within and outside of the department.
- Identify potential product performance issues and alert appropriate management personnel when needed.
- Work in conjunction and effectively communicate with various departments, including Legal Affairs, Regulatory Affairs, R&D, Manufacturing, Marketing, Medical Affairs, Sales and Customer Service
- Provide product performance expertise on cross-functional project teams as necessary.
- Expanding technical and clinical knowledge of current product portfolio and new products.
- Provide support during audits and regulatory inspections.
- Participate in networking events with internal customers.
- Performs other duties as required or assigned.

**Desired Profile**:

- Previous Regulatory Affairs, Quality Assurance experience in the Pharmaceutical and/or Medical Device industry- A minimum of 3 years practical experience in the pharmaceutical environment, with an international exposure
- Experience interacting with regulatory agencies such as the FDA.
- Quality Management Systems (QMS) experience preferred
- Writing and Verbal skills necessary to effectively communicate technical information to others.
- Comfortable and capable of using software programs (Word, Excel, PowerPoint) and a willingness to expand and increase these competencies.
- Involvement with field actions for drugs and/or medical devices preferred.
- BA/BS Degree in life science, engineering, business or equivalent.