Loading...
 
Share this Job

Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Regulatory Affairs Manager

About Us

 

 

At Guerbet, we build lasting relationships so that we enable people to live better.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.

 

Achieve, Cooperate, Care, and Innovate are the values ​​that we share and practice.

 

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

What we offer

Regulatory Affairs – Medical Device Manager - Based in Cincinnati

Summary of the position:

The Medical Device Regulatory Manager will assume the responsibility for the regulatory affairs team based in Cincinnati.  This role will be responsible for implementation and maintenance of internal and external medical device regulatory dossiers/ TFs, regulatory strategy throughout the product development lifecycle, and securing global regulatory approvals  The RA-Manager plays a key role in new product development teams and device change implementation as well as communicating with various global regulatory agencies including US FDA.

 

Essential functions:

  • Represents Regulatory on product development teams, developing/executing regulatory plans and providing regulatory impact information for project options.  
  • Ensures accuracy of data entry in RADAR, oversees document management, and supports business requirements during platform development
  • Responsible expert on EUDAMED and US FDA platform interface requirements
  •  Responsible for creation of medical device SOP’s at local and global level where required, and implementation of these SOP’s throughout Guerbet legal entities.
  • Track global regulatory changes, perform impact analyses and communicate this information to other shareholders.
  • Supports Regulatory Activities and Approvals related to Global Market Authorizations having direct contact with affiliates
  • Supports maintenance of platform accreditation and acts are regulatory interface for GDPR and other global data privacy requirements in the future for Medical Devices
  • Point of contact with staffing agencies and recruiters.  Oversees candidate review, interviews, and hiring of FTEs, contractors and co-ops. 

Required Skills

  • 5-7 years work experience in Medical Device Regulatory Affairs, preferably with regulatory submission and database experience.
  • Fundamental knowledge of both US and EU MD Regulatory paradigms
  • Superior attention to detail.
  • Excellent technology skills, particularly expertise with Microsoft Office (Word, Excel, etc.) applications.
  • Ability to manage projects and report out to higher management
  • Strong written and verbal communication skills.
  • Able to multitask effectively and work independently and make informed decisions