Globusmedical

Regulatory Associate

Audubon, PA

Sponsorship not specifiedDetected 16 days ago

ComplianceExcelClinical TrialsPatient CareFDA RegulatoryMedical DevicesCommunicationTime ManagementMicrosoft OfficeRegulatory Affairs

About the role

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.
Partnering with Product Development and management to prepare and review 510(k) submissions
Assisting in the completion of IDE submissions for IDE clinical trials

Knowledge of US Code of Federal Regulations Title 21
Strong time management skills, with the ability to work on multiple projects simultaneously
Preparing final 510(k) submissions and obtaining required management approvals
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
Bachelor's degree in health or science-related field, or equivalent
Minimum of 0-2 years' experience in medical device industry or equivalent, preferably within orthopedic medical devices
Excellent communication and listening skills
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
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

Performing routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports

Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception
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.
Globus Medical is an
All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship.

Improving patient care by delivering advanced technology to our customers is at the core of what we do.
We are passionate in our role in improving the lives of patients by continuously developing better solutions.
We listen to our customers' needs and respond with a sense of urgency.
Understanding 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
Customer Focused: We listen to our customers' needs and respond with a sense of urgency.
We are committed to a diverse workforce.
We are accountable to one another and support each other.
We pursue our mission with energy and passion.
We are nimble, results-oriented and decisive.
We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Globus Medical is an equal opportunity employer.
We value all employees' talents and support an environment that is inclusive and respectful.
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.

rd to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship

This listing is sourced directly from Globusmedical's careers page and normalized into a canonical job model.