welcome to graphic controls
  about graphic controls
  working at graphic controls
  available positions
  internships at graphic controls
  contact information
  send us an email


Job Openings >> Global Regulatory Affairs Specialist
Global Regulatory Affairs Specialist
Title:Global Regulatory Affairs Specialist
Location:Buffalo, NY

Nissha Medical Technologies is seeking a Global Regulatory Affairs Specialist to ensure compliance of medical devices to FDA, EU, ISO, and other international requirements to ensure compliance across multiple manufacturing facilities. This person will advise on and coordinate the approval and registration of medical devices, being a crucial link between the company, its products and regulatory authorities including the FDA, CMDCAS, EU Competent Authority, ISO registrar and applicable international authorities.

Essential Functions

  • Ensure that products comply with all regulatory requirements.
  • Manage Regulatory approvals with FDA, Health Canada, Notified Bodies, EU Competent Authorities, EU Representative and international authorities.
  • Conduct regulatory intelligence monitoring activities and advise management accordingly.
  • Prepare global regulatory approval submissions.
  • Monitoring and setting timelines for filing regulatory variations and renewals.
  • Ensure product labeling meets regulatory requirements.
  • Facilitate continual improvement process interfacing with all departments.
  • Collaborate with cross functional teams toward improvement of QMS.
  • Development and implementation of Quality and Regulatory-related training programs as required.


  • 3+ years’ experience in the medical device field.
  • RAC Certification preferred.
  • Demonstrated proficiency in leading cross functional groups to conclusions.
  • Acute attention to detail. Demonstrated ability to plan and organize projects.
  • Proficient on Microsoft Office product (Word, Excel, Access and PowerPoint).
  • Prior experience with FDA establishment registration, device listing, 510(k) or PMA submissions and prior experience with international submissions.
  • Strong understanding of medical device labeling requirements.

Knowledge Skills and Abilities

  • Commitment to excellence and high standards. Versatility, flexibility, and willingness to work with constantly changing priorities with enthusiasm.
  • RAC Certification preferred
  • Good judgment with the ability to make timely and sound decisions.
  • Creative, flexible, and innovative team player.
  • Excellent written and oral communication skills
  • Ability to work with all levels of management

Great benefits offered including medical, dental , 401K, education assistance, and more!


Nissha Medical Technologies is an Equal Opportunity Employer; and considers applicants for all positions without regard to race, color, religion, creed, gender, gender identity, national origin, age, disability, marital or veteran status, sexual orientation, or any other legally protected status. In addition, Graphic Controls will provide reasonable accommodations for qualified individuals with disabilities.

If you need assistance with completing the online application process, please call Graphic Controls at (716) 847-7592.

This opening is closed and is no longer accepting applications
Powered by ApplicantStack

Online Chat

About SSL Certificates


About Us
Our Green Initiative
Sign up for our Newsletter! sign up for our newsletter
ISO 9001:2008 Certified
ISO 13485:2003 Certified
Jobs at Graphic Controls


General Search
Chart Search
Pen Search
Medical Search



find us on facebook
view our linked in profile

Terms of Use | Site Map | Return Policy
USA: 716.847.7592 • Canada: 800.267.9498 • Latin America: 716.853.7500 • United Kingdom: +44 1803 860100 • Europe: +32 9228 1046
Copyright Graphic Controls, All Rights Reserved

The OEM trademarks identified herein are the trademarks of the respective OEMs, and not of Graphic Controls.
Graphic Controls disclaims any affiliation, connection or association between it's products and those of the respective OEMs.