Branch Medical Group · 3 months ago
Regulatory Associate
Audubon, PA
Full-time
Onsite
New Grad, Entry Level
0+ years expGlobus Medical is dedicated to improving the quality of life for patients with musculoskeletal disorders through innovation. The Regulatory Affairs Associate will assist in drafting and submitting FDA submissions for medical devices, ensuring compliance with relevant regulations and collaborating with internal teams to facilitate timely submissions.
Health CareManufacturingMedicalMedical Device
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
Qualification
Required
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
Company
Branch Medical Group
Branch Medical Group is manufactures medical implants and graphic cases.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
unknown2015-02-25Acquired
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