Quality and Regulatory Specialist

Data Innovations LLC

Location: Colchester, VT

Type: Full Time

Education: Bachelor's Degree

Experience: 3 - 5 Years

Essential Functions and Responsibilities of Quality and Regulatory Specialist at Data Innovations:

  • Develop and maintain procedures to ensure regulatory compliance.
  • Management of controlled documents including review and revision, as necessary.
  • Prepare regulatory filings, ensure statuses are maintained and documentation is complete, including but not limited to recalls, registrations, 510(k) submissions, CE Mark filings.
  • Accurately review and approve records documenting software hazard analysis, including ensuring product risk management procedures have been followed.
  • Attend and provide input in Design Review meetings and Known Issue (Complaint Handling Unit) meeting; including providing input to product hazard/risk assessment.
  • Review and approve release documentation and off-the-shelf testing documentation.
  • Ensure established quality and regulatory procedures are followed.
  • Lead and maintain Quality Events including CAPA incidents, as assigned, in the quality and regulatory queue.
  • Lead and/or participate in Quality Event investigations, as required.
  • Work closely with subject matter experts to ensure regulatory compliance and gain an understanding of products.
  • Keep management and team members informed about pertinent issues that may affect projects, products, the department or company.
  • Attain current certification as lead auditor (ISO 13485 lead auditor, ASQ CQA or DI trained lead auditor)
  • Schedule and perform internal audits as required.
  • Support and participate in external audits and inspections.
  • Update and accurately maintain departmental spreadsheets and reports, including Quality and Regulatory metrics.
  • Perform activities related to company training, including developing QMS training material and teaching QMS training, as required.
  • Accurately assist in the scheduling related to Quality and Regulatory training classes.
  • Accurately maintain controlled documents and records according to retention policies.
  • Participate in industry quality groups such as ASQ and RAPS.
  • Communicate with Business Partners and external contacts regarding the DI Quality System.
  • Perform other related duties as assigned, , including but not limited to, help monitor, maintain and improve the quality system


Knowledge, Skills, and Abilities:

  • Ability to understand concepts, practices and procedures relevant to DI’s market.
  • Proficient with Microsoft Office (Outlook, Word and Excel)
  • Ability to write clear, concise documents on a deadline.
  • Ability to communicate clearly and professionally in verbal and written formats.
  • Ability to multi-task in a dynamic environment with changing priorities
  • Strong ability to organize, manage workload, set realistic deadlines and manage multiple priorities without direct supervision.
  • Possess a strong attention to detail.
  • Meet travel requirements of the position.
  • Ability to follow DI’s policies and procedures and system usage practices.
  • Must comply with Company vaccination policy.
  • Experience with MasterControl preferred.


Education and/or Experience

Bachelor’s Degree with at least 2 years of related working experience– preferably in a regulatory environment OR a combination of education and related working experience from which comparable knowledge and skills can be acquired.


Physical Requirements/Working Conditions:
While performing duties of this job, the employee is predominately functioning in a sedentary light office position with high frequency of telephone communication, keyboarding, and computer.


Preferred skills and experience:

  • In addition to the above requirements, the ideal employee/candidate will have experience with the following: Direct working experience in healthcare or regulated industry dealing with matters associated with the FDA, ISO or other regulatory/certifying bodies.
  • Experience and familiarity of quality system requirements
  • Experience with computerized service, CRM and eQMS systems.
  • Understanding of HIPAA, GDPR and other privacy requirements.


Supervision Level

This person reports directly to the Director of Quality and Regulatory.

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