Position Summary:The International Regulatory Specialist drafts, submits and gains approval of product registrations and other submissions to international Regulatory agencies. This position entails development of submissions in conjunction with other Globus departments, requires working knowledge of products under review and of relevant regulations and guidance documents. This individual must be enthusiastic, positive, even-tempered and effective in building working relationships with cross-functional teams and international staff while following ISO, CE, FDA and international/local regulations. Travel may be required up to 10% of the time.
Essential Functions:- Partners with Product Development, Quality Assurance, and management to prepare and review international Regulatory submissions, including CE technical files, and other international filings, to obtain marketing clearance
- Obtains timely marketing clearance for all products in parallel with US submissions
- Provides Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations
- Coordinates, reviews and submits product labeling for marketing outside the United States
- Routinely maintains approved files, including coordination and preparation of amendments as necessary
- Reviews design changes and technical files for updates to documentation
- Files Certificates to Foreign Governments with FDA
- Develops relevant Regulatory SOPs as necessary
- Ensures conformance to ISO, CE, FDA and other international/local regulations.
- Understands the company's products, surgical techniques and the use of implant and instrument systems
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.
Qualifications:- BS degree in health or science-related field; Engineering degree is a plus
- Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, preferably within orthopedic medical devices
- Experience in medical device development and registration of products
- Demonstrated knowledge of international registration requirements and documentation; focus on EMEA, Japan, and Brazil as well as other key geographies.
- Experience assessing regulatory impact of product/process changes
- Experience reviewing labeling, promotional literature, etc.
- Excellent communication and listening skills
- Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
- Strong time management skills, demonstrated ability to work on multiple projects, priorities simultaneously
- Able to work independently as well as within a team
Physical Demands:The physical demands listed here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
Other Duties:Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
