About ECI
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About the role
Support the Regulatory Affairs NPI and Sustaining teams with technical, change control, document control, and change impact analysis activities according to corresponding product/project needs, such as:
What you'll do
- Routing documents for approval within the change control system.
- Perform gap assessments derived from global regulatory changes, by comparing standard/regulation versions and analyzing the significance of changes for an adequate and timely compliance.
- Support labeling changes by routing and coordinating the implementation of changes.
- Drafting reports and other related documentation in English.
- Creating and editing technical files and regulatory documents.
- Showing good understanding of GMP and compliance requirements.
- Overseeing that new product technical documentation meets the regulatory guidance provided by the system.
- Prepare and maintain a Project Tracker with weekly updates for Management Review.
- Other tasks as agreed upon between the Liaisons listed in this Statement of Work adequate to ECI's resource level.
What you will bring
- Bachelor’s Degree in Engineering.
- 4 -8 years of experience.
- Familiar with electronic management documentation.
- Spanish: Native Speaker, English: Fluent speaking, writing and reading.
ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
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