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:

The Regulatory Affairs Co-op will work daily with Guerbet colleagues responsible for device design, manufacture, and compliance in support of Guerbet’s medical imaging products. This position will work with our Regulatory Affairs, quality, engineering, and our global network of affiliates to support registration of products world-wide. Responsibilities will include compiling and/or maintaining a database of global registrations and product technical documentation to support new product introductions, registrations, and renewals of products globally.

This individual will be reporting to a member of the Regulatory Affairs team.

ESSENTIAL FUNCTIONS:

• Prepare domestic and international submissions (including CE-mark dossiers) for new products and product changes to facilitate timely approval of market access.

• Author dossier content for new device registrations and variations

• Provide support to new and currently marketed products including labeling advice and post market follow up activity requirements. Update of Technical Files and Design Dossiers as required along with developing strategy and creation of change notifications to regulatory agencies.

• Document Regulatory Activities and Approvals to support Global Market Authorizations. Ensure files maintain compliance with regulatory requirements.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Work directly with Affiliates and distributor partners to support product registrations worldwide.

• Compile technical information for regulatory submissions. In many instances, a STED document may need to be established.

• Represent Regulatory Affairs in various teams for new product development or support of lifecycle changes.

• On a regular basis update internal documentation to track registration approvals.

KNOWLEDGE, SKILLS AND ABILITIES:
 

• Ability to understand technical documentation related to device design and manufacture, such as product drawings, engineering test reports, product operator manuals and manufacturing process flows.

• Ability to effectively manage multiple responsibilities simultaneously

• Strong written and verbal communication skills

• Understanding of Microsoft Office, Excel, Word, etc.

• Willingness and ability to learn from others

• Demonstrated leadership and a team player

• Desire to work in a fast paced ever changing environment

• Ability to be agile as business needs change and shift frequently.

REQUIRED EDUCATION:

• Candidates must be an undergraduate student majoring in science, engineering, or related fields;

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

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