Regulatory Associate

Globus Medical•Audubon, PA

About The Position

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible. Position Summary : The Regulatory Affairs Associate assists in drafting, submitting and gaining 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, requiring 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.

Requirements

Bachelor’s degree in health or science-related field, or equivalent; Engineering degree is a plus
Knowledge of US Code of Federal Regulations Title 21
Minimum of 0-2 years’ experience in medical device industry or equivalent, preferably within orthopedic medical devices; Regulatory Affairs experience is a plus.
Excellent communication and listening skills
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
Strong time management skills, with the ability to work on multiple projects simultaneously
Able to work independently as well as within a team
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

Responsibilities

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 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
Assisting in Regulatory Pathway Form determinations under departmental guidelines
Administrative tasks, such as filing, scanning, organizing file, as needed.
Reviewing and filing 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
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
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.