Irvine Scientific
Clinical Affairs Specialist
Irvine Scientific, Santa Ana, California, United States, 92725
We are hiring a Clinical Affairs Specialist. The Clinical Affairs Specialist will be responsible for assisting in the development and generation of Clinical Evaluation Plans and Reports (CEPs, CERs), conducting clinical literature searches, performing analysis of clinical literature, and evaluating and reviewing clinical data, generated both pre and post-market for medical devices and in vitro diagnostic devices. In addition, the Clinical Affairs Specialist will assist in performing annual activities associated with Post Market Surveillance (PMS) program, including but not limited to, preparing and writing plans, reports and Post Market Clinical Follow-Up (PMCF).Responsibilities:
Collaborate on project schedule, timelines and project tracking tools for Clinical Evaluation, PMS and Post Market Clinical Follow-up (PMCF) processes for all medical devices and IVDs.Assist in the development and preparation of the Clinical Evaluation Plan and Clinical Evaluation Reports (CERs) per MDR 2017/745 and MEDDEV2.7.1 to meet essential requirements in support of submission for CE mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance (class IIb and III products).Assist in providing evaluation of clinical and safety data assessments of post-marketing events.Assist in creation of PMCF plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents.Conduct systematic, comprehensive searches of published clinical literature; assist in writing clear and effective generation of search protocols and reports, examination of clinical evidence and provide input to risk assessment and product labeling as well as clinical / regulatory strategies.Stay current on clinical research and developments as well as literature related to FUJIFILM Irvine Scientific products. Provide critical analysis and summary as needed.Assist with collecting, analyzing, trending and reporting on safety data to proactively identify potential adverse safety risks or performance trends.Ensure, in conjunction with R&D and other personnel, that the clinical requirements of the product are adequately addressed.Assist with organization and execution of pre-launch clinical usability trials in conjunction with R&D, as needed.Collaborate with cross-function team members to ensure compliance to applicable regulations, standards, and company policies.Preparation of relevant information / responses for regulatory submissions, working with other members of the RA department.Assist in the preparation and maintenance of product registrations that include, but are not limited, to the following:
Renewal of Technical Files and communication with corresponding Agents (EU AR, China, etc.).US FDA 510(k) Premarket Notifications.Technical Files for EU and EU AR.
Assist with, but not limited to, the following:
Internal/External and Customer Audits, as it relates to clinical data.Change assessment to product design, specifications, or product manufacturing processes.Writing and/or revising regulatory related standard operating procedures.Preparing monthly reports on product registration status.
Collaboratively provide clinical expertise including establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and reports/data presentations/publications.Perform periodic reviews of risk documentation, product labeling, and marketing brochures as part of the clinical evaluation process.Required Skills/Education:
B.S. or B.A. required.A minimum of 1-2 years of combined experience in clinical research, medical writing, clinical science in the medical device and/or pharmaceutical industry.Familiarity with clinical trial design, conduct, and oversight.Experience in EU Class III products and clinical trials a plus.Experience/knowledge in writing CERs and/or PMS plans in accordance with Meddev 2.12.2 and MDR.Ability to interpret regulatory standards, guidance and laws.Knowledge in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses or literature summaries.Strong scientific and medical writing skills.Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures.Strong written and verbal communication skills.Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.Ability to obtain cooperation from other groups and lead cross functional teams.Experience in cell, tissues culture and/or embryology, a plus. Experience can be from education or industry.Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments.Ability to write, edit, speak and read English well.Salary and Benefits:
For California, the base salary range for this position is $100,090 to $130,295 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
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Collaborate on project schedule, timelines and project tracking tools for Clinical Evaluation, PMS and Post Market Clinical Follow-up (PMCF) processes for all medical devices and IVDs.Assist in the development and preparation of the Clinical Evaluation Plan and Clinical Evaluation Reports (CERs) per MDR 2017/745 and MEDDEV2.7.1 to meet essential requirements in support of submission for CE mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance (class IIb and III products).Assist in providing evaluation of clinical and safety data assessments of post-marketing events.Assist in creation of PMCF plans and reports, and Summary of Safety and Clinical Performance (SSCP) documents.Conduct systematic, comprehensive searches of published clinical literature; assist in writing clear and effective generation of search protocols and reports, examination of clinical evidence and provide input to risk assessment and product labeling as well as clinical / regulatory strategies.Stay current on clinical research and developments as well as literature related to FUJIFILM Irvine Scientific products. Provide critical analysis and summary as needed.Assist with collecting, analyzing, trending and reporting on safety data to proactively identify potential adverse safety risks or performance trends.Ensure, in conjunction with R&D and other personnel, that the clinical requirements of the product are adequately addressed.Assist with organization and execution of pre-launch clinical usability trials in conjunction with R&D, as needed.Collaborate with cross-function team members to ensure compliance to applicable regulations, standards, and company policies.Preparation of relevant information / responses for regulatory submissions, working with other members of the RA department.Assist in the preparation and maintenance of product registrations that include, but are not limited, to the following:
Renewal of Technical Files and communication with corresponding Agents (EU AR, China, etc.).US FDA 510(k) Premarket Notifications.Technical Files for EU and EU AR.
Assist with, but not limited to, the following:
Internal/External and Customer Audits, as it relates to clinical data.Change assessment to product design, specifications, or product manufacturing processes.Writing and/or revising regulatory related standard operating procedures.Preparing monthly reports on product registration status.
Collaboratively provide clinical expertise including establishing and approving scientific methods for design and implementation of clinical protocols, data collection systems and reports/data presentations/publications.Perform periodic reviews of risk documentation, product labeling, and marketing brochures as part of the clinical evaluation process.Required Skills/Education:
B.S. or B.A. required.A minimum of 1-2 years of combined experience in clinical research, medical writing, clinical science in the medical device and/or pharmaceutical industry.Familiarity with clinical trial design, conduct, and oversight.Experience in EU Class III products and clinical trials a plus.Experience/knowledge in writing CERs and/or PMS plans in accordance with Meddev 2.12.2 and MDR.Ability to interpret regulatory standards, guidance and laws.Knowledge in writing clinical study reports, integrated summaries of safety and performance, abstracts, manuscripts, clinical risk/benefit analyses or literature summaries.Strong scientific and medical writing skills.Exceptional ability to manage multiple projects in a fast-paced environment, with changing priorities and significant time pressures.Strong written and verbal communication skills.Proficient in Microsoft Word, Excel, PowerPoint, Adobe Acrobat.Ability to obtain cooperation from other groups and lead cross functional teams.Experience in cell, tissues culture and/or embryology, a plus. Experience can be from education or industry.Must be able to work and make independent decisions, understand complex scientific and clinical data information, and be able to take the initiative to lead projects and assignments.Ability to write, edit, speak and read English well.Salary and Benefits:
For California, the base salary range for this position is $100,090 to $130,295 annually. Compensation for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience, location, etc.).Fujifilm is an equal opportunity employer to all, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation, and any other status protected by federal, state, or local law.
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