US & Canada         Other Countries/Languages: Latin America | Europe

Innovation

Our Leadership Team continues to invest in our associates - Our forward looking culture is like no other.

Health & Wellness

With a focus on healthy mind and body,  we strive to expand health and wellness incentives across our global operations.

Global Force

We bring together leading cultures and innovators - Join our dynamic and a culturally rich work environment.

Changing the World

Vermed products change the pace of patient care with innovative wireless monitoring.


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.

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

Advancement Opportunities

We believe in promoting and growing talent from within! Employees are offered opportunities to apply for open positions.

Compensation and Benefits

Specific benefits will vary by location. In general they include:

  • Competitive Financial Compensation
  • Training and Development
  • Healthcare Coverage
  • Health and Wellness Incentives
  • Disability Protection
  • Tuition Reimbursement
  • Retirement Plans
  • Service Awards

Diversity EEO Statement

Graphic Controls is an Equal Opportunity Employer. Graphic Controls considers applicants for all positions without regard to race, color, religion, creed, gender, national origin, age, disability, marital or veteran status, sexual orientation, or an other legally protected status.

Culture

For over 60 years, Graphic Controls has been a Company that values it's employees and their hard work. Employees are offered great benefits and opportunities which make coming to work everyday something to look forward to. Employee satisfaction is proven by the simple fact that our average length of service is over 15 years.