Careers That Change Lives
Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees around the world.
A Day in the Life
As the Associate Regulatory Operations Specialist, you will be part of the Regulatory Operations function, covering regulatory activities across Asia Pacific, the Americas and Europe.
Responsibilities may include the following and other duties may be assigned.
Responsible for the preparation, publication, quality control, and delivery of paper and electronic components of regulatory submissions and overall regulatory information (initial, amendments, product life cycle updates) Ensure that submissions and related processes are produced with electronic publishing tools in compliance with document management standards. Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, project support, and providing input to systems designs. Ensure continuous efficiency and effective process improvement measurements are conducted to evaluate external vendors. Prepare, submit, track, index and archive: paper and electronic regulatory requirements in different regulatory systems and tools
Must Have: Minimum Requirements
Bachelor’s Degree is required 0 years of experience required
Your Profile
Preferably minimum of 1 year in Regulatory Operations or relevant function, within a medical devices or pharmaceutical company, Contract Research Organization, or similar industry Bachelor's Degree in Allied Sciences or equivalent field (Pharmacy/Biological Science/Engineering) Previous hands-on experience with Microsoft Office tools, such as Office and Excel (V-Look Up) Background on Medical Devices regulations is a plus Knowledge on scientific and technical documentation, able to read and understand technical concepts such as test report, raw data, drawings, is a plus Previous hands-on experience with database, regulatory systems, SAP, Calyx, RDR, Power BI is a plus Able to communicate with different stakeholders, across a high matrix organization
