Regulatory Affairs Specialist
Location: Carlsbad, CA
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 Regulatory Affairs Specialist is responsible for world-wide regulatory submissions in support of product registrations and approvals for Ortho Organizers, Inc.
ESSENTIAL RESPONSIBILITIES & ACCOUNTABILITIES:
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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
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.
Able to apply the basic concepts of algebra.
Henry Schein(NASDAQ: HSIC),, a Fortune 500® company selling in over 200 Countries and a member of the NASDAQ 100® Index, is the largest provider of health care products and services to office-based practitioners . Henry Schein believes in “doing well by doing good.” For the 12th consecutive year, Henry Schein was included in Fortune’s list of the World’s Most Admired Companies, ranking #1 in our industry for corporate social responsibility, global competitiveness, quality of management, quality of products and services, and use of corporate assets. We were again named to Ethisphere's list of the World's Most Ethical Companies. Our Henry Schein Cares activities extended access to care by advancing wellness, building health care capacity, and enhancing disaster relief efforts around the world. Our flagship programs continued to lead the way during 2013: Give Kids A Smile; Healthy Lifestyles, Healthy Communities; Back to School; Think Pink, Practice Pink; Holiday Cheer for Children; were all visible and effective ways that we demonstrated our commitment to global corporate social responsibility and the values that make Henry Schein a very special company.
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.