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International Product Registration Specialist (R104389)

Company Name: Henry Schein
Location: Carlsbad, CA
Job Type: Quality Assurance/Regulatory
Contact Name: Marie Hunter
Email:  (Please apply here for this position.)
Salary: Dependent on experience

Job Description

Henry Schein Orthodontics, is a leading U.S. manufacturer of orthodontic products for the domestic and international orthodontic markets. Henry Schein Orthodontics provides a vast array of innovative products, services, and educational courses to help build successful practices. In the USA, our products are marketed to orthodontic practitioners through a strong direct sales force, and internationally, our products are sold in more than 85 countries through 160+ distributors. We are dedicated to provide the orthodontic profession with high quality, innovative products backed by attentive customer service and educational support. At Henry Schein Orthodontics everyone is part of the team, with the same goal; to improve patient care and continue to “Advance the Future of Orthodontics” for generations to come.

The International Product Registration Specialist is responsible for world-wide regulatory submissions in support of product registrations and approvals for Ortho Organizers, Inc.

Job Requirements

Specialized Knowledge and Skills:
Excellent organizational skills and extreme attention to detail.

Ability to prioritize, multi-task and adapt to change.

Ability to work effectively in a team environment and build strong working relationships.

Ability to respond in a timely manner to inquiries from regulatory agencies.

Word processing skills, including Microsoft Word, Excel and PowerPoint.

MATHEMATICAL SKILLS:
Able to apply the basic concepts of algebra.

1. Prepare and submit dossiers to register new products, amend current product registrations and re-register existing product registrations with foreign agencies, including CE technical file preparation and maintenance.

2. Respond effectively to international government agencies regarding inquiries/requests for additional information.

3. Prepare and submit Certificate to Foreign Government applications with the FDA.

4. Facilitate administrative and technical phases of regulatory submission, including coordination of legalization activities of documents.

5. Proven ability to take the initiative to independently research various international regulations and formulate and communicate a comprehensive report based on research findings.

6. Ability to maintain a supportive partnership with Manufacturing, Engineering, Sales/Marketing, and QA to accomplish objectives.

7. Ability to adhere to time sensitive registration requests and deadlines to ensure global sales opportunities are met.

8. Ability to make sound judgment decisions regarding registration timelines which ultimately effect inventory plans, sales and operations goals.

9. Ability to track and monitor progress of submissions, approvals and renewals.

10. Prepare monthly status reports for the Regulatory Affairs Management.

11. Requires regular, reliable attendance.

12. Participates in special projects and performs other duties as required.


Experience: Bachelor's Degree (BA/BS) from four-year college/university. Four years related experience in an FDA-regulated industry or equivalent combination of education, training and experience. Skilled in MS Office suite and MS Windows, Adobe Acrobat.

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please apply here:   https://henryschein.taleo.net/careersection/hsi1/moresearch.ftl?lang=en