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.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)
