- Description:
- Execution of regulatory change control for device labels and package inserts for newly licensed products (systems include: Trackwise event tracking system)
- Responsible for coordinating / processing product and process changes that range from simple to complex within an Electronic Data Management System.
- Responsible for interfacing with intra / inter - departmental associates on change management.
- The scope of this role is responsible for carrying out the daily operations of the Change Management function as it pertains to product labeling, design control projects and device master records maintenance .
- Works with Manufacturing, Marketing, Purchasing and Regulatory to provide an initial analysis of implementation timing, potential scrap costs and quantities of new labeling to be ordered.
- Assists labeling change owners and junior staff with the creation of design change plans.
- Responsible for updating design change logs and analyzing labeling changes for impact to Device Master Records.
- Creates and maintains the Design History Files for assigned development projects per the approved procedures.
- Review records for good DHF documentation practices, adherence to the DHF Document Change Control requirements and determine the need for Reference Pointer Forms.
- Maintain the Master Action Item List and the DHF Index Responsible for file maintenance and record keeping Performs other duties & projects as assigned
Skills:
EDMS, Doc Control, Labeling
Additional Skills & Qualifications:
• Product Lifecycle Management: MasterControl, Veeva Vault and Electronic Document Management System (EDMS).
• Excellent verbal and writing skills
• Ability to handle multiple projects simultaneously and to prioritize tasks
• Ability to follow detailed instructions, maintain accurate records, complete assignments in a thorough, conscientious fashion while adhering to company procedures and QSR compliance.
• Advanced knowledge of Microsoft Office applications (Word, Excel, PowerPoint and Visio).
• Experience with Adobe Acrobat Professional.
• Familiar with federal and other regulations, e.g. QSR's, ISO 13485, CMDR, IVDD
• Demonstrates commitment to the development, implementation and effectiveness of our Quality Management System per ISO, FDA, and other regulatory agencies.
• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
• Follow all safety guidelines, manufacturing policies and procedures. Operate under QSR compliance.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email for other accommodation options.