Regulatory Affairs Specialist
Company: Henry Schein Orthodontics
Position: Regulatory Affairs Specialist
Location: Carlsbad, CA
Posted: February 15, 2021
***Please complete and submit your application for consideration at the link below***
Come Join our Team!
Henry Schein Orthodontics, is a leading U.S. manufacturer of orthodontic products for the domestic and international orthodontic markets. We provides a vast array of innovative products, services, and educational programs to help orthodontic practitioners deliver exceptional care to their patients, while concurrently building 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 and treatment solutions, 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.
This position is responsible for the preparation, compilation of product submissions, license renewals, periodic updates and registrations to regulatory agencies worldwide and labeling and promotional material review and approval. This position is granted the authority by the Director, RA/QA to take any actions required to fulfill the scope, duties and responsibilities of this position
ESSENTIAL RESPONSIBILITIES & ACCOUNTABILITIES:
- Prepare and submit registration dossiers to ensure compliance with the FDA, Health Canada, EU Competent Authorities, etc., for timely registration approvals.
- Create, review and maintain CE Technical Files and make appropriate submittals to the EU Representative and Notified Body to ensure compliance with the Medical Device Directive and Medical Device regulation.
- Provide guidance, review and approval of promotional and advertising materials, product claims, training materials, Instructions for Use, labels and other related labeling to ensure compliance with regulations.
- Assist with post market surveillance activities, i.e., adverse event reporting and field corrective actions.
- Create, maintain and ensure accuracy of regulatory documentation, including but not limited to: 1) MAUDE Post Market Surveillance and 2) CER's for branded products at required intervals.
- Represent RA in New Product Meetings to establish regulatory strategy, classification, hazard class and regulatory applications, as required.
- Review and implement change requests and notifications as they impact regulatory documentation.
- Work cross functionally to ensure timely submission of international requests.
- Participate in meetings with regulatory agencies when required.
- Support the preparation of Audit documentation when required.
- Assist in authoring department reports to ensure internal metrics are met.
- Stay current on applicable FDA, ISO (including risk management) and other applicable industry requirements.
- Participate in special projects and performs other duties as required.
In addition to the essential duties and responsibilities listed above, all positions are also responsible for:
- Meeting company standards pertaining to quantity and quality of work performed on an ongoing basis, performing all work related tasks in a manner that is in compliance with all Company policies and procedures including Worldwide Business Standards.
- Adhering to Company policies, procedures, and directives regarding standards of workplace behavior in completing job duties and assignments.
Four-year degree in sciences or health-related field with 2-4 years related experience; OR 5 - 7 years prior experience as a Regulatory Affairs Specialist in a medical device regulated facility.
Hands-on experience with international registrations a must, preferably in the dental device industry.
SPECIALIZED KNOWLEDGE & SKILLS:
- Ability to effectively problem-solve through critical thinking and root-cause analysis with
- Minimal direction and make decisions with confidence
- Excellent organizational skills and attention to detail
- Excellent written and verbal communication skills to include interacting with both internal personnel and external organizations (regulatory authorities, customers, distributors, etc.)
- Ability to prioritize, multi-task and adapt to change
- Ability to work within budget constraints and to work with minimal guidance to perform job function
- Ability to respond in a timely manner to inquiries and complaints from regulatory agencies
- Word processing skills, including Microsoft Word, Excel, and PowerPoint
This position will be working in an office environment, utilizing typical office equipment
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 14th 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 such as: 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