AddressDescription
Description:
Responsible for managing regulatory changes for product labels and package inserts of newly licensed products using the Trackwise event tracking system. Tasks include coordinating and processing simple to complex product and process changes within an Electronic Data Management System. Collaborating with internal teams on change management. This role involves overseeing daily operations related to product labeling, design control projects, and device master records maintenance. Working closely with Manufacturing, Marketing, Purchasing, and Regulatory departments to analyze implementation timing, potential scrap costs, and new labeling quantities. Assisting junior staff with design change plans, updating design change logs, and analyzing labeling impacts on Device Master Records. Creating and maintaining Design History Files for development projects. Ensuring compliance with DHF documentation practices and Document Change Control requirements. Managing the Master Action Item List and DHF Index. Responsible for file maintenance and record keeping. Other duties and projects may be assigned.
Skills:
Proficiency in EDMS, Document Control, and Labeling.
About Actalent
Actalent is a prominent player in providing engineering and sciences services and talent solutions globally. They support companies in advancing engineering and science projects by connecting them with specialized experts who enhance scalability, innovation, and speed to market. With a vast network of consultants and clients across various regions, Actalent caters to numerous Fortune 500 companies.
Diversity, Equity & Inclusion
Actalent focuses on fostering diversity, equity, and inclusion as key drivers of success and fairness within the organization. These values are ingrained in the culture through initiatives such as:
- Recruiting a diverse workforce
- Fostering an inclusive environment through continuous self-assessment
- Cultivating a culture of care, engagement, and recognition with tangible outcomes
- Providing growth opportunities for employees
The company upholds equal employment opportunities for all applicants, regardless of race, gender, age, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information, or any other characteristic protected by law.
If needed, applicants can request reasonable accommodations during the application or interview process due to a disability. For accommodation requests, please reach out through the provided contact information.
