The Regulatory Affairs Specialist is responsible for world-wide regulatory submissions in support of product registrations and approvals for Ortho Technology, Inc.
- 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.
- Respond effectively to international government agencies regarding inquiries/requests for additional information.
- Prepare and submit Certificate to Foreign Government applications with the FDA.
- Facilitate administrative and technical phases of regulatory submission, including coordination of legalization activities of documents.
- Proven ability to take the initiative to independently research various international regulations and formulate and communicate a comprehensive report based on research findings.
- Ability to maintain a supportive partnership with Manufacturing, Engineering, Sales/Marketing, and QA to accomplish objectives.
- Ability to adhere to time sensitive registration requests and deadlines to ensure global sales opportunities are met.
- Ability to make sound judgment decisions regarding registration timelines which ultimately effect inventory plans, sales and operations goals.
- Ability to track and monitor progress of submissions, approvals and renewals.
- Prepare monthly status reports for the Regulatory Affairs Management.
- Requires regular, reliable attendance.
- Participates in special projects and performs other duties as required.
Intermediate level professional; developing knowledge within own discipline. Some evaluation, originality or ingenuity required to perform tasks. Frequently apply the fundamental concepts, practices, and procedures of a particular field. Apply company policies and procedures to resolve a variety of issues.
Work on problems of limited to moderate scope and impact where analysis of situations or data requires a review of a variety of factors. Analyze possible solutions using standard procedures to solve straightforward problems. Exercise judgment within defined procedures and practice to determine appropriate action. Build productive internal/external working relationships.
Receive a moderate level of instruction on day-to-day work and detailed instruction and guidance on new projects or assignments.
MINIMUM WORK EXPERIENCE:
Typically 2 to 4 years of related professional experience.
Typically a Bachelor's Degree or global equivalent in related discipline.
GENERAL SKILLS & COMPETENCIES:
- Basic understanding of industry practices
- General proficiency with tools, systems, and procedures
- Basic planning/organizational skills and techniques
- Good decision making, analysis and problem solving skills
- Good verbal and written communication skills
- Basic presentation and public speaking skills
- Basic interpersonal skills
- Developing professional credibility
SPECIFIC KNOWLEDGE & 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
- Skilled in Adobe Acrobat
- Word processing skills, including Microsoft Word, Excel and PowerPoint
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.
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Job Field: Administrative