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

Requirements

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.