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 >> Manager, Regulatory Compliance
Manager, Regulatory Compliance
Title:Manager, Regulatory Compliance
Location:Buffalo, NY
Graphic Controls, a Nissha Company, is seeking a Manager of Regulatory Compliance to ensure compliance of medical devices to FDA, EU, ISO, and other international requirements. 

Essential Functions
  • Manage QMS for compliance to regulatory and statutory requirements.
  • Ensure that products comply with all regulatory requirements.
  • Manage Regulatory interfaces with FDA, Health Canada CMDCAS, Notified Body, EU Competent Authority, EU Representative and international authorities.
  • Conduct regulatory intelligence monitoring activities and advise management accordingly.
  • Prepare submissions of regulatory variations and renewals to oversight agencies.
  • Monitoring and setting timelines for filling regulatory variations and renewals.
  • Ensure product development teams maintain compliance to design controls requirements.
  • Manage auditing functions internal, external, 2nd and 3rd party.
  • Coordinate clearance and response of non-conformities resulting from 2nd and 3rd party audits.
  • Train internal auditors in regulatory requirements.
  • Assess effectiveness, verifies and closes corrective/preventive actions.
  • Facilitate continual improvement process interfacing with all departments.
  • Lead cross functional teams toward improvement of QMS.
  • Development and implementation of Quality related training programs as required.
  • Bachelor's Degree.
  • Minimum 3 years Regulatory experience in the medical device industry.
  • ISO 13485 Certified Lead Auditor preferred.
  • Prior experience with FDA establishment registration, device listing and 510 (k) or PMA submissions.
  • Prior experience with international submissions.
  • Proven ability to handle multiple projects and meet deadlines.
  • Knowledge of applicable regulations and standards.
  • Proven leadership and business acumen skills.

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


Graphic Controls, a Nissha company, 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.