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Openings >> Global Regulatory Affairs Specialist
Global Regulatory Affairs Specialist
Summary
Title:Global Regulatory Affairs Specialist
ID:1709
Department:Quality
Location:Buffalo, NY
Description

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.

Requirements

  • 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
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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.