Hello Everyone, Greetings of the day. This is Vydehi from Intellectt Inc. We currently have an opening for a Regulatory Affairs Analyst with one of our medical device clients. If you or anyone you know is interested in this opportunity, please feel free to send your updated resume to vydehi@intellectt.com or reach out to me directly at +1 732 355 7412. Role : Regulatory Affairs Analyst Location : Burlington, MA Duration : 8-12 Months 100% Onsite role (Only Local Candidates are applicable) Skills Looking For Entry-level position, but some relevant experience or exposure to regulatory affairs is beneficial. The project involves post-market surveillance, focusing on qualitative data related to patient experiences with medical devices, specifically the Heartmate pump. It is a computer-based role, with no hands-on involvement with the product. Strong time management, organizational skills, and ability to manage priorities effectively. Basic knowledge of Microsoft Office software. Background in STEM fields preferred, particularly biomedical engineering. Basic proficiency in Microsoft Office software is required. Day-to-day Responsibilities: Analyzing qualitative data regarding patient experiences with medical devices; Making decisions based on FDA regulations and international regulations; Collaborating with healthcare professionals, engineers, and field coordinators; Managing conflicting priorities and effectively communicating with team members. Education And Level Of Experience Bachelor's degree is required, preferably in STEM fields such as biomedical engineering. Entry level role (0 to 2 years of experience). Fresh graduate: Academic Achievements, Internships or Volunteer Work, Extra curricular activities during course work Overqualification Criteria Candidates with higher education levels (e.g., PhD or Masters) or extensive experience in the regulatory field may be considered overqualified for the entry-level nature of the role. Top 3 Skills Strong time management and organizational skills. Ability to manage priorities effectively in a fast-paced environment. Basic proficiency in Microsoft Office software. Interview Process Initial phone screening lasting 20-30 minutes followed by In-person interview. #J-18808-Ljbffr
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