Medical Affairs Specialist
Proclinical is currently recruiting for a Medical Affairs Specialist for our client located in Irvine, CA. Successful candidate will provide Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups.
- Report to the Manager, Franchise Medical Affairs for the therapeutic space
- Franchise Life Cycle Management Support, with currently marketed products
- Experience with Medical Writing for Notified Body (NB) submissions
- 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
Skills and Requirements:
- A minimum of 5-6 years of clinical, engineering or life science experience is required.
- Relevant degree is preferred (PhD, RN, BSc etc, Electrophysiology nurse or catheter lab technician, nurse practitioner (NP), or physician's assistant (PA)).
- Demonstrated knowledge and experience in quality compliance, regulatory compliance, and healthcare compliance is preferred.
- 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).
- Knowledge of MEDDEV Laws and guidelines for Medical Devices of all Classes
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please Maya Smith at (+1) 267-405-6995 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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