Medical/Legal/Regulatory (MLR) Specialist

Requisition ID:  35112  

 

At Terumo Blood and Cell Technologies, our 8,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve. Advancing healthcare with heart.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Join us and help shape wherever we go next. You create your future and ours.

 

Associate Regulatory Operations Specialist

 

JOB SUMMARY

Working with general supervision, provides regulatory support by performing administrative registration and licensing activities. Associate will also have responsibilities including process and/or system maintenance, regulatory administration, assisting with publishing global submissions, along with other assignments as required.

 

ESSENTIAL DUTIES

• Supports the regulatory department in the change control process workflow.
• Supports the maintenance of online content for the Global Regulatory Department.
• Supports the maintenance of existing simple licenses, certificates, and government authorization letters.
• Supports regions with the review and approval of letters required for government agencies.
• Submits requests for Certificates to Foreign Governments to the Food and Drug Administration.
• Processes documents for Legalization and/or Apostile.
• Supports the Regulatory department by assisting with submissions to regulatory agencies that may include review of content for document grammar, proper electronic links, and other document formatting.
• Supports efforts to improve regulatory business process efficiency with improved utilization of the enterprise systems by creating and maintaining data reports that meet business unit or geography needs.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Two year technical degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

 

Experience

2 years experience in one of the following areas:

• Experience in a medical device or regulated industry
• Experience with document preparation for regulatory agencies

• Experience with document management systems

 

Skills

• Strong interpersonal, oral, presentation, and written communication skills
• Ability to understand end-audience needs and requirements
• Ability to work collaboratively and across groups
• Strong analytical problem-solving skills
• Ability to prioritize and multi-task
• Advanced Microsoft Office Skills: Excel, Word, and Outlook

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

 

PHYSICAL REQUIREMENTS

Typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasionally lifting up to 20 pounds.

 

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.  Reasonable accommodations may be made to enable individuals with disabilitie