Job Description

JOB SUMMARY:

This position is responsible for the preparation,compilation of product submissions, license renewals, periodic updates andregistrations to regulatory agencies worldwide and labeling and promotionalmaterial review and approval. This positionis granted the authority by the Director, RA/QA to take any actions required tofulfill the scope, duties and responsibilities of this position

ESSENTIAL RESPONSIBILITIES & ACCOUNTABILITIES:

* Prepare and submit registration dossiers to ensure compliancewith the FDA, Health Canada, EU Competent Authorities, etc., for timelyregistration approvals.
* Create, review and maintain CE Technical Files and makeappropriate submittals to the EU Representative and Notified Body to ensurecompliance with the Medical Device Directive regulation.
* Provide guidance, review and approval of promotional andadvertising materials, product claims, training materials, Instructions forUse, 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 regulatorydocumentation, including but not limited to: 1) MAUDE Post Market Surveillance and 2) SDSs for OrthoTechnologybranded products at required intervals.
* Represent RA in New Product Meetings to establish regulatorystrategy, classification, hazard class and regulatory applications, as required.
* Participate in special projects and performs other duties asrequired.

In addition to the essential duties and responsibilitieslisted above, all positions are also responsible for:

* Meeting company standards pertaining to quantity and qualityof work performed on an ongoing basis, performing all work related tasks in amanner that is in compliance with all Company policies and procedures includingWorldwide Business Standards.
* Adhering to Company policies, procedures, and directivesregarding standards of workplace behavior in completing job duties andassignments.

PHYSICAL ACTIVITIES:

This position will be working in an office environment, utilizing typical office equipment
Qualification

EXPERIENCE:

Four-yeardegree in sciences or health-related field with 3-5 years related experience;or 5 - 7 years prior experience as a Regulatory Affairs Specialist in a medicaldevice 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 androot-cause analysis with
* Minimal direction and make decisions with confidence
* Excellent organizational skills and attention to detail
* Excellent written and verbal communication skills to includeinteracting with both internal personnel and external organizations (regulatoryauthorities, customers, distributors, etc.)
* Ability to prioritize, multi-task and adapt to change
* Ability to work within budget constraints and to work withminimal guidance to perform job function
* Ability to respond in a timely manner to inquiries andcomplaints from regulatory agencies
* Word processing skills, including Microsoft Word, Excel, andPowerPoint

OTHER:

LANGUAGESKILLS

Ability to read, analyze, and interpret general businessperiodicals, professional journals, technical procedures, or governmentalregulations. Ability to write reports,business correspondence and procedures. Ability to effectively present information and respond to questions fromgroups of managers, clients, customers and the general public.

REASONING ABILITY

Ability to define problems, collect data, establish facts,and draw valid conclusions. Ability to interpret a variety of instructionsfurnished in written, oral, diagram or schedule form.

Henry Schein,Inc. is an Equal Employment OpportunityEmployer and does not discriminate against applicants or employees on the basisof race, color, religion, creed, national origin, ancestry, disability that canbe reasonably accommodated without undue hardship, sex, sexual orientation,gender identity, age, citizenship, marital or veteran status, or any otherlegally protected status