Sr. Labeling Business Partner
Irvine, CA HASH(0x61ea638)
Global Business Unit Labeling Specialist Responsibilities:
- Drive labeling activities to initiate and deliver to Operations labeling content changes through updates to product labels, instructions for use (IFU) and other forms of regulated labeling materials, in compliance with global and regional standards and regulations.
- Responsible for engaging cross-functional teams to resolve obstacles, meet key labeling objectives, and collaborate on continuous improvement initiatives.
- Support development of solutions for labeling initiatives
- Bachelors Degree (Science related preferred, but not required)
- Minimum of 5 years labeling experience in either Medical Device Industry or Pharmaceutical
- Minimum of 2 years experience developing labeling for medical devices for FDA and global markets and developing/improving documentation (i.E. SOPs) in an FDA regulated industry
- Project Management Professional (PMP) Certificate preferred
- Strong relationship management and communication skills, both oral and written, in order to influence others and operate effectively with ambiguous situations
- Salary between $90k-105k annually
- Comprehensive Benefits package
- Possible Relocation benefits for the ideal candidate