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Job Openings >> Manager, Regulatory Compliance
Manager, Regulatory Compliance
Summary
Title:Manager, Regulatory Compliance
ID:1246
Department:Quality
Location:Buffalo, NY
Description
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.
Requirements
  • 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.

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