Jr. Regulatory Affairs Specialist - (30032)

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'RE LOOKING FOR

We are seeking a dedicated and detail-oriented Regulatory Affairs Specialist to join our team. This role is crucial in ensuring regulatory compliance for a portfolio of medical devices used with Guerbet’s contrast media. You will be responsible for assembling dossiers for global submissions and playing a key role in device change implementation. This is a hybrid position located in Cincinnati, Ohio.

YOUR ROLE

Prepare international submissions (including CE-mark dossiers) for new products and product changes to facilitate timely approval of market access.
Communicate directly with international affiliates and distributor partners' regulatory personnel.
Author dossier content for new device registrations and variations.
Represent Regulatory on product development teams, developing and executing regulatory plans and providing regulatory impact information for project options.
Assess and respond to deficiencies issued by health authorities in response to new registrations, variations, renewals, etc.
Document regulatory activities and approvals to support global market authorizations and ensure files maintain compliance with regulatory requirements.
Act as a liaison with other departments, e.g., Quality, R&D, supply chain, marketing, vigilance, and medical affairs for support of major initiatives.
Support internal and external audits/inspections as required (EU notified bodies, FDA, etc.).
Author and train on regulatory-related standard operating procedures and work instructions as required.
Compile technical information for regulatory submissions and update internal documentation to track registration approvals.

YOUR BACKGROUND

Education:

BS in Engineering, Science, or related degree; or MS in Regulatory Science.

Experience:

1-2 years’ work experience in Medical Device Regulatory Affairs, preferably with FDA and EU-notified bodies submission and international regulatory filings.

Skills/Competencies:

Good understanding of US, EU, and Canada regulations on medical devices.
Superior attention to detail.
Excellent technology skills, particularly expertise with Microsoft Office (Word, Excel, etc.) applications.
Strong written and verbal communication skills.
Ability to multitask effectively and work independently with international oversight.
Experience with medical device product registration and licensing is required.
Good record-keeping skills.
Ability to handle multiple tasks/projects.
Previous experience with Class II/III medical devices preferred.
Experience drafting regulatory submissions for product approval preferred.

EQUAL EMPLOYMENT OPPORTUNITY

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant based on race, color, religion, national origin, sex, age, disability, veteran or military status, genetic information, pregnancy or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Applicants may be entitled to reasonable accommodation due to disability, pregnancy or related medical condition, or a sincerely held religious belief. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing an undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.

Guerbet will not discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.

WHY GUERBET? 

4 weeks of PTO 

Insurance benefits start date of hire

Competitive 4% 401K match + 2% profit sharing contribution 

Tuition reimbursement program for ongoing education

Paid time off for select volunteer opportunities