Four-year degree in sciences or health-related field is required; advanced degree preferred.
Minimum 5-years experience in regulatory affairs. Medical device experience a must, preferably in thedental device industry with pharma a plus. Expert knowledge of FDA, QSR, ISO 13485, Canadian Medical Device Regulations, the Medical Device Directive (MDD) and applicable international requirements required. Extensive experience with managing complex regulatory projects for global filings and experience working with regulatory agencies, e.g., FDA and DEA, and state health boards. Must be self-motivated with the ability to work with all levels throughout the organization.
Specialized Knowledge and Skills:
- Demonstrated ability to lead and manage projects
- Ability to effectively problem-solve through critical thinking and root-cause analysis with minimal direction and make decisions with confidence
- Excellent organizational skills and extreme 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 to no guidance to perform job function
- Ability to work effectively in a team environment and build strong working relationships
- Ability to read, analyze and interpret common scientific and technical journals, legal documents, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents
- Ability to respond in a timely manner to inquiries and complaints from regulatory agencies
- High degree of initiative and self-motivation with a strong sense of accountability
- Word processing skills, including Microsoft Word, Excel, and PowerPoint
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence and procedures. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
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