Share this Job
Date:  Jan 1, 2023
Location: 

Princeton, NJ (USA), US

Job Type:  Graduate

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:

This is the key US regulatory role to ensure preparation, review and finalization of accurate and timely submissions of all US regulatory documents for medical devices and software driven medical devices.

 

YOUR ROLE:

Coordinate efforts associated with the preparation, review and submission of  all domestic and international regulatory documents for medical devices and software driven medical devices.
Identify and interpret relevant guidance documents, international standards, or consensus standards for medical devices and software driven medical devices.   
Ensure through training programs or through the appropriate communication tools that new regulations are understood and followed by everyone, and that the appropriate regulations  are included in the updated corporate policies and the corporate procedures.

 

YOUR RESPONSIBILITES:

  • Keep current on all US federal regulations for medical devices and software driven medical devices in order to ensure regulatory requirements and regulatory processes are understood, implemented  and followed.
  • Act as internal liaison for both internal and external customers for the regulatory questions related to medical devices and software driven medical devices.
  • In partnership with the Senior Regulatory team, participate in all interactions with US FDA pertaining to the regulatory processes for medical devices and software driven medical devices

 

  • Maintain the current knowledge of the existing and the emerging regulations, standards or the new regulatory guidance documents.
  • Recommend changes to the company procedures in response to changes in regulations or standards.
  • Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
  • Prepare or maintain technical files as necessary to obtain and maintain approvals.
  • Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
  • Write or update standard operating procedures, work instructions, or policies.
  • In partnership with the Senior Regulatory Affairs team, communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review.
  • Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
  • Compile and maintain regulatory documentation databases or systems.
  • Determine the types of regulatory submissions or types of internal documentation that are required for the proposed medical device/product changes or the proposed labeling changes.
  • Participate in the internal or the external audits.
  • Prepare or direct the preparation of additional information or responses as requested by regulatory agencies.
  • Provide technical review of test data or test reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity.
  • Review clinical protocols to ensure collection of required data needed for regulatory submissions.
  • Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires.
  • Escort government inspectors during inspections and provide post-inspection follow-up information as requested.
  • Analyze product complaints and make recommendations regarding their reportability.
  • Maintain and facilitate the Quality Document System.
  • Coordinate recall or market withdrawal activities as necessary.
  • Review and file medical device reports in accordance with regulatory agency guidelines. 


YOUR BACKGROUND:

Education Required/Preferred:

  • Bachelor’s degree in a scientific field is required. RAC is preferred.

Experience:

  • 4 to 7 years of experience in medical device industry regulatory affairs is required.
  • Experience with maintaining a variety of regulatory affairs database systems.
  • At least 4 plus years of hands-on experience with filing required regulatory documents with the US FDA and/or appropriate government agencies.
  • Demonstrated experience with FDA interactions and understanding of regulatory processes.

Qualifications/Skills/Competencies:

  • Proven track record of project management skills.
  • Excellent interpersonal skills, ability to manage conflicting points of view and negotiate an appropriate resolution to issues, while ensuring compliance with applicable regulations.
  • Good communications skills, both written and verbal. 
  • Must be able to convey scientific and sometimes complex issues in a clear concise manner to ensure understanding across a very diverse employee population.
  • Analytical Skills
  • Database Management
  • Attention to Details
  • Problem Solving
  • Building relationships
  • Diplomacy
  • Teamwork


***This sign on bonus only qualifies to non-agency candidates. Other stipulations to the sign on bonus may apply.

 

EQUAL EMPLOYMENT OPPORTUNITY

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, 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 identify, and maintain employment statistics on applicants.

 

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing 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 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.

 

WHY GUERBET? 

  • 4 weeks of PTO 

  • Exempt-employee benefits start on start date, non-exempt benefits start a month after hire 

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

  • Tuition reimbursement program for ongoing education


Nearest Major Market: New Jersey