International Regulatory Specialist
At Globus, we move with a sense of urgency to deliver innovations that improve the quality of life of patients, inspired by the surgeons and healthcare providers who treat them.
Our world-class engineering works to transform clinical insights into tangible musculoskeletal solutions. We are constantly in pursuit of better patient care, and we understand that speed is critical because life cannot wait. Join us!
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 development teams and international staff while following ISO, CE, FDA and international/local regulations. Travel is required up to 10-20% of the time.
The responsibilities of the position include, but are not limited to, the following:
- Partnering with Product Development, Quality Assurance, and management to prepare and review international Regulatory submissions, including CE technical files and design dossiers, and other international filings, to obtain marketing clearance
- Obtaining timely marketing clearance for all products in parallel with US submissions
- Providing Regulatory oversight of changes in manufacturing facilities, processes, and procedures, as these changes pertain to international regulations
- Coordinating, reviewing, and submitting of product labeling for marketing outside the United States
- Routinely maintaining approved files, including coordination and preparation of amendments as necessary
- Reviewing design changes and technical files for updates to documentation
- Filing Certificates to Foreign Governments with FDA
- Developing relevant Regulatory SOPs as necessary
- Ensuring conformance to ISO, CE, FDA and other international/local regulations.
- Understanding the company’s products, surgical techniques and the use of implant and instrument systems
- Adhering to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies. Ensure 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
- Representing 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
In order to be qualified for this role, you must possess the following:
- 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
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.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus.
Globus Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.