Sr Labeling Lead

Location

Aliso Viejo, California, USA

Department Name

646-R&D Management

Qualifications

1. Bachelor’s degree or equivalent combination of education and experience. 
2. Minimum five (5) years of relevant experience in product labeling in medical device field. 
3. Minimum one (1) year of experience in project management in a related field. 
4. Ability to design and modify labels, IFUs, and Patient Implant Cards. 
5. In depth knowledge of relevant labeling standards (e.g. 21 CFR 801 – Labeling, 21 CFR 820 – Device Labeling, 21 CFR 830 – Unique Device Identification, FDA 89-4203, ISO 15223, CDRH Guidance Document, etc.). 
6. Advanced experience with MS Visio
7. Ability to Create, Update and Maintain MS Project GANTT’s
8. Excellent written and verbal communication skills.
9. Proficient with MS Office applications, including Word, Excel, Outlook, and Teams. 

1. Strong knowledge of global regulations and guidelines pertaining to labeling. 
2. Demonstrated ability to understand the implications of label changes on pending and approved labels. 
3. Ability to present labeling design and implementation strategies to obtain alignment from stakeholders (including upper management). 
4. Ability to write, review, and approve labeling procedures accurately. 
5. Ability to translate regulation requirements into practical procedures. 
6. Demonstrated skills in project management. 
7. Experience successfully managing multiple projects with the ability to motivate cross-functional teams to complete their assigned tasks. 
8. Skills in team leadership and development. 
9. Ability to work effectively and confidently in a team environment. 
10. Ability to multi-task and prioritize projects to meet deadlines. 
11. Minimum three (3) years of experience in project management. 
12. Minimum seven (7) years of relevant experience in product labeling in medical device field. 

External-Facing Title

Sr Labeling Lead

Posting Country

US - United States

Salary Range

$91,500 - $120,000 (Compensation could be higher based on education, experience and skill sets)