Documentation and Quality/Regulatory Manager
Data Innovations, LLC - South Burlington, VT

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Data Innovations North America, the world’s largest and most successful clinical and blood laboratory Middleware Company, is currently seeking a Quality and Regulatory Manager. The Data Innovations’ Quality and Regulatory Manager is the Management Representative to the Quality System and as Safety Officer for medical devices (according to § 30 of the German Act on Medical Devices). This person has the authority and responsibility to ensure that the quality management system is implemented, maintained and continuously improved on a world-wide basis. This person has the ultimate responsibility in ensuring system and practices comply with the relevant government, industry and customer/partner regulatory standards. This person is also responsible for leading, providing guidance, training, and mentoring on regulatory strategy on a global basis. The Quality and Regulatory Manager is expected to rely on extensive experience and judgment to work independently, accomplish goals and perform the essential functions and responsibilities of the job.

Essential Functions and Responsibilities:
Lead and manage all activities of the Quality and Regulatory operations of the business, to include foreign operations

Evaluate, develop and maintain company-wide procedures to ensure regulatory compliance on a world-wide basis

Evaluate quality and regulatory risks and notify Executive Management of potential non-compliance and other findings that could have adverse impact to the company

Responsible for ensuring all necessary regulatory applications and statuses are maintained and filed

Act as liaison to all regulatory bodies for communications pertaining to the regulatory process for products requiring approval, certification or clearance

Responsible for administrating the CAPA system

Identify, analyze and communicate new laws, regulations and corporate policies to appropriate parties

Serve as the Company’s Privacy Officer and ensure continuous compliance with HIPAA regulations

Independently ensures established quality and regulatory procedures are followed

Assists with certifying the Company’s products and services meet established quality levels and clearance standards

Manage the internal and external audit process, as well as the Finding Resolution Process

Update internal website and ensure companywide compliance with the document control strategy

Attend and participate in Leadership meetings

Establish, implement and report on departmental goals, objectives, policies, and operating procedures

Manage and report on Quality, Regulatory and Compliance metrics

Demonstrate expert level awareness of the DI Quality System

Manage and provide appropriate Quality System training and guidance to employees

Train, mentor and serve as a resource to other members of the team and cross-departmental colleagues regarding quality and regulatory questions

Responsible for assessing training needs, job performance, management and resource allocation of staff

Review, interpret and summarize all Regulatory/Compliance standards including but not limited to FDA, ISO, Health Canada, CE, HIPAA and other government security and privacy regulations.

Acts as Safety Officer for Medical Devices (according to § 30, German Act on Medical Devices)

Perform other related duties as assigned
Requirements

Knowledge, Skills, and Abilities:
Complete or be able to complete a recognized Regulatory Affairs Certification and Safety Officer training program(s)

Extensive experience and familiarity of quality system requirements

Proficient with Microsoft Office (Outlook, Word and Excel)

Extensive experience with project planning and project management and ability to remain on-task

Ability to manage through shifting priorities of a project, team and company

Proven ability to conceptualize and correctly evaluate business and/or user requirements and needs

Excellent analytical skills, problem solving skills and ability to resolve problems quickly in their entirety

Proven ability to write clear, concise documentation that is technical in nature on a deadline

Proven ability to communicate clearly and professionally in verbal and written formats with both internal and external customers

Ability to work independently and make decisions on business matters

Ability to follow DI’s policies and procedures

Experience with writing work instructions, process mapping and design

Experience with compliance assessment and compliance planning development

Ability to interpret key metrics established

Thorough understanding of customer and business partner needs
Education and/or Experience
Bachelor’s Degree and at least seven years working experience related to Quality and Regulatory matters OR at least 10 years 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:

Fundamental knowledge and experience in medical devices and their application

Experience with CRM products

Experience with Microsoft SharePoint
Supervision Level
This person reports directly to the Director of Operations and also has the responsibility to lead and mentor a team.