Regulatory Affairs Quality Specialist Position

3 weeks ago


Raleigh, North Carolina, United States Lifelancer Full time
Job Title: Regulatory Affairs Quality Specialist Position

Company OverviewAt Intelerad, we are committed to providing innovative medical imaging software solutions that revolutionize healthcare. With over 20 years of experience and a global presence across 11 time zones, our team is dedicated to delivering cutting-edge technology that makes a real difference in patients' lives.

We believe in the power of collaboration and community, which is why we have created a workplace that encourages teamwork, promotes well-being, autonomy, and creativity. Our talented professionals are passionate about solving problems and making a positive impact on the world of healthcare.

The Regulatory Affairs Quality Specialist plays a vital role in ensuring compliance with regulatory requirements, maintaining certifications such as ISO 13485, MDSAP, and CE mark, and integrating quality management systems into company processes.

Estimated Salary Range$90,000 - $120,000 per year, depending on experience and qualifications.

Job Description

Key Responsibilities:

  • Manage Corrective and Preventative Actions (CAPAs) within set timeframes.
  • Maintain QMS documentation and ensure proper retention of documents and records.
  • Participate in activities related to adverse events and recalls, including reporting, notification, and follow-ups.
  • Supervise and coordinate external QMS audits.
  • Conduct and/or coordinate internal QMS audits to ensure compliance with legal, regulatory, and ISO standards.
  • Provide advice and take action in response to audit findings and recommendations regarding information security.
  • Coordinate third-party audits to assess the adequacy of controls in place to protect the organization's information.
  • Oversee and participate in the creation of QMS training materials and provide training as required.
  • Develop RAQ education programs and training sessions.
  • Participate in Quality meetings, set new metrics, and ensure existing metrics are gathered, analyzed, and acted upon.
  • Analyze and identify solutions to improve QMS efficiency.
  • Work on special projects related to the organization's goals, including reports, statistics, and research.
  • Collaborate with Privacy and Quality Managers to integrate new regulatory requirements into current processes.
  • Participate in other projects as deemed necessary by Intelerad.

Required Skills and Qualifications:

  • 3+ years of experience in quality management systems.
  • Bachelor's degree in business, quality management, or related field (or equivalent).
  • Knowledge of ISO 13485, MDSAP, and EMDR requirements.
  • Proficiency in MS Office, Google Suite, and Visio (or similar workflow tools).
  • Experience in the IT / software (SaaS) and/or medical device field (SaMD / SiMD)
  • Working knowledge of common security standards such as SOC 2 and ISO 27001 preferred.

Benefits:

  • A competitive salary range of $90,000 - $120,000 per year.
  • A comprehensive benefits package, including medical, dental, and vision insurance.
  • A generous paid time off policy, including vacation days, sick leave, and holidays.
  • Opportunities for professional growth and development, including training and certification programs.
  • A dynamic and supportive work environment, with a focus on teamwork and collaboration.


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