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 Regulatory Affairs Specialist drafts, submits and gains clearance clearance for 510(k) submissions, and approval for IDE/PMA submissions to the Food and Drug Administration (FDA) for class II and class III products. This position entails development of FDA submissions, 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 internal teams while following FDA 21 CFR regulations.
The responsibilities of the position include, but are not limited to, the following:
- Partnering with Product Development and management to prepare and review 510(k) submissions
- Preparing final 510(k) submissions and obtaining required management approvals
- Submitting 510(k) documents and responding to the FDA in a timely manner
- Assisting in the completion of IDE and PMA submissions for IDE clinical trials
- Helping to prepare PMA packages, including non-clinical, manufacturing, and clinical sections
- Working with personnel in various functional areas to obtain timely submissions to FDA
- Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
- Reviewing Document Change Orders for Regulatory compliance, including drawings and labeling changes
- Performing routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
- Training new staff on relevant Regulatory processes as necessary
- Determine Regulatory Pathway for new/changed products under departmental guidelines
- Review and approve Regulatory Pathway Forms and supporting documentation
- Reviewing and approval of Note-to-File documentation for minor changes to 510(k) cleared products or systems
- Understanding the company’s products, surgical techniques and the use of implant and instrument systems
- Developing relevant Regulatory SOPs as necessary
- 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:
- Bachelor’s degree in health or science-related field, or equivalent; 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 US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus
- 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, color 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.