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Lead Specialist in Regulatory Affairs

2 months ago

Danvers, Massachusetts, United States Samsung NeuroLogica Full time
Position: Lead Specialist in Regulatory Affairs

Company Overview:NeuroLogica Corp., a proud subsidiary of Samsung Electronics Co. Ltd., stands at the forefront of cutting-edge medical imaging technologies. Our mission is to provide advanced diagnostic solutions that empower healthcare professionals around the globe. As part of the Samsung family, we are committed to innovation and excellence in the healthcare imaging sector.

Job Responsibilities:
  • Develop and submit regulatory documentation for the introduction of new products
  • Oversee regulatory initiatives for medical imaging technologies
  • Engage with regulatory bodies internationally
  • Refine regulatory processes and methodologies
  • Keep abreast of global regulations and share relevant updates
  • Evaluate labeling and marketing materials for compliance with regulations
  • Collaborate across departments to facilitate product approvals
  • Provide guidance during regulatory audits
  • Ensure adherence to worldwide regulatory standards
  • Foster teamwork and cooperation within the regulatory team
  • Effectively communicate with both internal and external stakeholders
  • Maintain comprehensive knowledge of all products offered by the company
  • Participate in mandatory training sessions and meetings
  • Manage time effectively and prioritize responsibilities
Qualifications:
  • Bachelor's degree in Engineering or a related field
  • Minimum of 3 years of regulatory experience in the medical device sector
  • Demonstrated success with FDA submissions and international regulatory approvals
  • Technical expertise in CT, X-Ray, and Ultrasound technologies
  • Exceptional written and verbal communication abilities
  • Capacity to work autonomously as well as collaboratively
Benefits:
  • Comprehensive health insurance
  • Dental and vision care options
  • Company-sponsored disability coverage
  • 401k retirement plan with matching contributions
  • Wellness initiatives and educational reimbursement
NeuroLogica is dedicated to fostering diversity and equal opportunity. Join our innovative team and contribute to shaping the future of medical imaging.