Globusmedical

Globusmedical

Regulatory Specialist

Audubon, PA

Sponsorship not specifiedDetected 16 days ago
ComplianceExcelClinical TrialsPatient CareFDA RegulatoryMedical DevicesCommunicationTime ManagementMicrosoft OfficeRegulatory Affairs

About the role

  • The Regulatory Affairs Specialist assists with 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.
  • Assists in the completion of IDE and PMA submissions for IDE clinical trials
  • Helps to prepare PMA packages, including non-clinical, manufacturing, and clinical sections

Requirements

  • Experience assessing regulatory impact of product/process changes
  • Experience reviewing labeling, promotional literature, etc.
  • Strong time management skills, demonstrated ability to work on multiple projects, priorities simultaneously
  • Prepares 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 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
  • 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:

Nice to have

  • Engineering degree is a plus
  • Demonstrated knowledge of US regulatory submissions
  • Pre-Sub, and 510(k)
  • working knowledge of IDE and PMA submissions a plus

Compensation

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

Benefits

  • Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
  • 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.

Company info

  • 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.
  • 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.
  • 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.

Equal opportunity

  • 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.

Visa & Work Authorization

  • rd to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship
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This listing is sourced directly from Globusmedical's careers page and normalized into a canonical job model.