Job Specifications: Job Title: Postmarket Surveillance Analyst Location: Burlington, MA, 01803 Duration: 8 Months + (extension chances depending on business needs.) Salary Range: $32.00 to $33.00 an hour on W2 Job Description: We are seeking a high caliber, team player as Product Surveillance Coordinator. Working under general supervision, receives, reviews, and investigates medical device complaints and maintains quality documents to ensure compliance with various regulatory agencies. Does not require instructions for routine assignments; requires some general instructions for new or special assignments. Takes initiative to ensure work is done accurately and completely. Applies existing work methods to different known situations. Problems involve recurring, routine situations; usually refers only to significant deviations from approved policy/practice to supervisor or more senior-level Product Surveillance personnel for resolution. Impact this role will have on the Company:On a daily basis, reviews and processes all incoming customer comments related to product quality and patient safety. Oversees the input of information documenting same into the database. Reviews clinical study data and assesses the need for supplemental reports as new information is received. Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Performs other related duties and responsibilities, on occasion, as assigned. Work additional hours, days, or schedules (including other shifts, weekends, and/or holidays), if directed. Your experience(s), education, and knowledge will further expand the company's success:Requires a bachelor’s degree or higher in Health/Sciences. Two or more years of complaint handling experience in a closely related field in the medical device and/or pharmaceutical industry or equivalent. Incumbents are required to work cooperatively and productively with others. Must be able to manage your time. Incumbents must also be able to meet deadlines on multiple projects. The ability to read, write, and communicate effectively in English is also required; this requirement includes clear, understandable speech and demonstrated comprehension skills. Incumbents are required to have demonstrated spelling, punctuation, grammar, basic math/numerical, and organizational skills. The demonstrated ability to understand and comply with applicable U.S. Food & Drug Administration (FDA) regulations and Company operating procedures, processes, policies, and rules is essential. Must be able to demonstrate a working proficiency in operating a personal computer and possess the ability to perform basic word processing/spreadsheet tasks using applications such as MS Word and Excel. Must be able to maintain regular and predictable attendance; the ability to work overtime. Excellent time management skills Your preferred qualifications and education:Working knowledge of LVADs. Candidate with a working knowledge of relevant Codes of Federal Regulations (CFRs) and International Organization for Standardization (ISO) regulations. Medical terminology and mechanical circulatory systems knowledge Application Process:Apply online; You can reach me at 919-230-9952 ext. 4186 and also email me keerti.mishra@spectraforce.com. Application Submission; we will reach out to you over the phone to discuss important aspects of this job opening and upon agreement, your profile will be submitted to the client for review. Interviews; Depending on the size of the selection committee, several interviews are scheduled for each candidate. We will coordinate with candidates to set up interviews with our client Job offers; After completion of all the interviews, Hiring Manager confers and evaluates applicants based on the interviews, job experience, skills and talent assessments, and all other relevant information (recommendations, e.g.). A top choice should be identified and agreed on. Background checks; After Job offer, background checks would be conducted to review candidates’ criminal record, to verify employment history and eligibility, and to run credit checks. Drug testing may also be warranted, depending on the nature of the job. On-boarding; Based on the background checks, first-day reporting details would be shared with the candidate upon the client's instructions. Job offer: After completion of all the interviews, Hiring Manager confers and evaluates applicants based on the interviews, job experience, skills and talent assessments, and all other relevant information (recommendations, e.g.). A top choice should be identified and agreed on. I look forward to hear from you. If you are interested in discussing the role, please include your updated resume, the best number to reach you at and your availability for a phone call.