Regulatory Affairs, Clinical and R&D InternLocation

　　US-PA-MalvernID

　　2024-1149CategoryProduct Development

　　Position TypeIntern

　　Overview

　　Position Overview:We are seeking an energetic, resilient, tech savvy, responsible, organized intern to join our growing organization! Interns will follow a structured program, learning how our organization operates and contributing to our mission, vision and values. The Regulatory Affairs (RA) Intern should be majoring in engineering or health/life sciences.This program will begin in May and end in August for a total of 8 weeks, and will require participants to be onsite in our home office located in Malvern, PA. This internship experience will be required to work 40 hours per week, Monday through Friday with an 8:30am-5pm schedule. Interns will be compensated for their time.About Neuronetics:Neuronetics is a commercial stage medical technology company focused on designing and marketing products that improve the quality of life for patients who suffer from psychiatric disorders. NeuroStar Advanced Therapy is the leading transcranial magnetic stimulation (TMS) device and was the first TMS device designed for clinical use for the treatment of patients with Major Depressive Disorder. We are passionate about transforming patients' lives and the practices of our physician customers!Essential Duties/Responsibilities:* Provide entry to intermediate-level professional services, under supervision of professional staff and/or faculty personnel, as appropriate to the day-to-day operating objectives of the department.* Undertake and/or participate in projects and programs designed to develop professional skills and expertise appropriate to the needs of the organization.* Participate in the planning and implementation of department projects and initiatives within area of expertise, specifically:o UDI remediationo Complaint/MDR remediationo US and International product registrations (e.g., technical file creation)o Literature reviews & summaries for specific projectso Trial Master File (TMF) structuring and organizationo Projects that expose you to clinical research data management, clinical outcomes registry, clinical studies and more.* Receive guidance, training, and mentoring from professional personnel in planning and carrying out activities and assignments.* Administrative tasks may include taking notes and memos during meetings, typing documents, reporting, and/or managing files.* Attend company functions and networking events if applicable.* Other Duties as needed or required.Knowledge, Skill, and Abilities:* Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, and Excel)o SharePoint experience a bonuso Power BI experience a bonus* Excellent written and verbal communication skills* Organizational skills* Project-planning skills* Self-directed and self taught at times, with the ability to work without supervision* Energetic and eager to tackle new projects and ideas* Ability to multitask* Adaptable and flexible with the ability to work well in high-pressure, time sensitive situationsEducation and Experience:* Bachelor's degree or currently enrolled in an accredited college or university in a related field of studyo Junior, Senior or Graduate Student* Must be at least 18 years of age* Minimum overall GPA of 3.0Physical Requirements:* Standing/Sitting 50/50%* Walking/Bending/Stooping 50%*Applicants must be authorized to work for any employer in the US. We are unable to sponsor or assume responsibility for employment visa/work authorization at this time.

　　Neuronetics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Neuronetics makes hiring decisions based solely on qualifications, merit, business needs at the time.