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Medical Affairs Specialist

Company: Kelly Services
Location: Irvine
Posted on: November 11, 2019

Job Description:

Kelly Services??? Outsourcing & Consulting Group (OCG) has an opening for a Medical Affairs Specialist in the Irvine, CA area. This position can be done remotely but candidates need to reside near Irvine and be able to work onsite as required.?? This is a long-term, open-ended opportunity with benefits. ?? The Medical Affairs Specialist will provide Franchise Life Cycle Management support for catheters for AFIB so cardiac or electrophysiology experience is ideal. This position involves a lot of literature review and managing publications, regulatory submissions and working with quality documents so requires medical writing for Notified Body (NB) submissions experience. The right candidate should be able to work independently and be able to change gears fairly quickly. The Medical Affairs Associate attends many R&D calls, works with global teams and may be expected to help in preparation of audits. Individuals in this role will not be running as the lead on projects initially, however there may be opportunities in the future.?? ?? Other Job Duties Include: Provide labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups Collaborate closely with the franchise medical manager on MDR revisions and documentation needs including risk document review and literature ???? Oversee literature review analysis and conclusions for CERs, and for MDR submissions (Clinical Reviews) Provide review of CERs and assist in preparation of periodic safety reports for assigned products Provide initial hands on management of publications and maintain timelines Research, prepare and document responses to Medical Information Requests from Healthcare providers ?? Technical & Leadership Competency Requirements?????????????? Proven track record of marketed product support (including development and compilation of regulatory documents such as CERs; labelling updates and copy approval). Deep understanding of device vigilance and a track record including analysis of safety data and contributions to decision making regarding benefit:risk ratios. Proven track record of human clinical (medical) experience. Additional experience in a surgical field and/or clinical research is highly desirable. Deep understanding of literature synthesis (including developing a research strategy, reviewing literature, and data extraction and analysis). Experience working with MEDDEV, knowledge of Laws??and guidelines for Medical Devices of all Classes required; experience with MDR a plus. Experience in performing targeted searches of the published medical literature in PubMed, OVID or Scopus is required. Marketed product support - including development and compilation of regulatory documents such as CERs; labelling updates and copy approval Effectively manage in a matrix environment and demonstrate influence capabilities Demonstrate effective Change Management Strong Project Management/process Development skills required Excellent communication (presentation and writing) skills are required. Proven leadership and proven ability to drive results working with a team of individuals is required. ?? Education & Experience Requirements A minimum of 5-6 years of clinical, engineering or life science experience is required; medical device experience. Some direct patient contact is preferred. Relevant degree (PhD, RN, BSc etc. Electrophysiology nurse or catheter lab technician, nurse practitioner (NP), or physician???s assistant (PA)). Demonstrated knowledge and experience in a medical device and/or quality/regulatory/healthcare compliance environment. 3 years??? experience working in a cardiac or Cath lab required; operating room experience is preferred. MS Office experience is required Ability to bring your own device/laptop ?? If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration! ?? This position comes with enhanced benefits which include: 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%) * Paid sick days and vacation days* ?? Perks of being a Kelly employee: Weekly electronic pay Access to more than 3,000 online training courses though Kelly Learning center Online application system Never an applicant fee ?? *benefits to be received upon meeting eligibility requirements ?? Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume.?? Why Kelly ?? ? The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ?? ) is one focus within the full array of Kelly Services?? workforce solutions. Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage. The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs. About Kelly Services ?? As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter . Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.

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Kelly Services

Keywords: Kelly Services, Irvine , Medical Affairs Specialist, Healthcare , Irvine, California

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