May 02, 2022

Regulatory and Quality Assurance Specialist

  • UltraLinq Healthcare Solutions
  • Remote (Raleigh-Durham, Durham, NC, USA)
Full time Quality Regulatory

Job Description

What and who we are: UltraLinq is a SaaS cloud-based medical image solution. We give our clients the ability to read, store, report and archive medical images anytime and from anywhere with an internet connection. We are a mature SaaS company with a startup mentality. Our team solely consists of passionate, motivated problem-solvers dedicated to providing exemplary service to our customers as we improve the healthcare experience for healthcare providers and professionals. We nurture a casual, diverse, and energetic atmosphere with highly supportive co-workers.

Who we need: We are currently seeking a Regulatory and Quality Assurance Specialist to join our team in our New York, NY or Durham, NC office. This is a great position for someone who enjoys working as part of a small team and leading in the maintenance and expansion of regulatory processes.

Why you should apply: If you are looking to make a significant impact in the Quality and Regulatory Assurance space, this position may be right for you. You will be a vital team member, providing assistance all quality initiatives across multiple countries and regulatory agencies.

How to succeed in this role: A successful candidate is someone who enjoys understanding the depths of the regulatory landscape and is interested in being a significant contributor to the team. To join our team, you’ll need to be a quick and flexible thinker and eager to learn as much as you can to help bring swift action to our future plans.

In this position you will:

  • Stay up to date on all relevant regulations issued by regulatory authorities impacting the company.
  • Participate in the development of the Quality System and be a key contributor for all regulatory topics.
  • Implement quality and regulatory plans and processes, conduct internal audits, and lead external audits.
  • Manage our Quality Management Software system.
  • Review and maintain risk management files such as DFMEA.

Experience:

  • 3+ years of experience in the implementation of quality management systems in an FDA and ISO 13485 regulated industry.
  • 2+ years of experience leading external audits, including FDA, ISO 13485 and ISO 27001
  • 2+ years of experience working with a Quality Management Software system, such as GreenLight Guru

Requirements:

  • Undergraduate or Advanced Degree (B.S., M.S.)
  • Experience working in a multi-national regulatory environment
  • Experience with HIPAA, ISO 13485, ISO 14971, and other medical device regulations.
  • Experience with ISO 27001, SOC 2, and other IT system compliance certifications.
  • Experience working in a software-based medical device company required.
  • Experience with a cloud-based medical device preferred.
  • Experience with GreenLight Guru preferred.
  • Excellent verbal and written communication skills.

Benefits: UltraLinq values personal and professional balance and growth that’s demonstrated through our offered benefits. Some of which include health insurance offerings, 401K offerings, pre-tax commuter benefits, a flexible Vacation policy, and a Vacation Incentive.

Application Instructions: Along with your resume, please submit a cover letter explaining your interest in joining or continuing in the Healthcare IT industry. Must be based in the US. Sponsorship not available.

A note about our commitment to equal opportunity and diversity:
All qualified persons eligible to work in the United States are encouraged to apply including, but not limited to, all nationalities, religions, gender identities, ages, ancestries, sexual orientations, marital statuses, disabilities, military services, or other non-merit factors.


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