Senior Regulatory Affairs Specialist- REMOTE
Global Medical Device Manufacturing Company Los Angeles, CA
- Expired: over a month ago. Applications are no longer accepted.
REMOTE -Senior Regulatory Affairs Specialist 6-12 months Contract
Develop and execute global regulatory strategy for new and/or modified drugs and/or medical devices to gain approval for clinical investigations and/or commercial distribution.
Also responsible for evaluating clinical data, published medical and scientific literature to support and generate meta-analyses, Clinical Evaluation Reports (CERs) and comprehensive Common Technical Document (CTD) clinical summaries.
· Develop regulatory strategy through investigation and evaluation of regulatory history/ background, classification, disease, harmonized/ recognized standards, etc.
· Prepare submissions and/or documents supporting submissions to gain approval for clinical investigations and/or commercial distribution, such as: IDE, CTAs, ITAs, IND, NDA, DINAs CTD, eCTD, Marketing Authorizations (MA), 510(k), PMA, Technical Files, and Letters to File etc.
· Critically evaluate clinical data, published medical and scientific literature, to support and generate scientifically fair-balanced documents, such as literature reviews, meta-analyses, CTD clinical summaries and CERs
· Contribute to developing and maintaining positive relationships with regulatory agencies through oral and written communications regarding pre-submissions strategies/ regulatory pathway development, submissions and follow-up on submissions under review to ensure timely approval/clearance.
· Advise project and/or product development teams on regulatory requirements for quality, preclinical and clinical data requirements for clinical study applications and/or marketing applications.
· Assess the acceptability of quality, preclinical and clinical documentation for submission filing to comply with regulatory requirements for clinical investigations and marketing applications
· Evaluate proposed preclinical, clinical and manufacturing changes for impact to submissions under
review or current clearance/ approvals
· Review collateral material associated with new launches and ongoing product support
· Develop and/or modify regulatory procedures, work instructions and templates
· May direct work of Specialist or Sr. Specialist
· 4-6 years of experience in a FDA and/or Health Canada regulatory industry with 2+ years’
experience in clinical/ scientific research
· Demonstrated proficiency in applicable clinical research regulatory requirements; i.e., Good Clinical
· Prior experience with clinical writing, e.g. abstract development, meta-analysis and literature
search protocols and reports
· Demonstrates strong project management, writing, coordination, and execution of regulatory
items, with emphasis on technical and scientific regulatory activities
· Demonstrates knowledge and skills in areas of regulatory pathways, risk-benefit analysis,
communication and collaboration internally and external, submission, registration, obtaining
approval/clearance, documentation, post marketing compliance, etc.
· Demonstrates developing of advanced technical leadership skills within the department
· Possesses and applies a broad knowledge and understanding of the regulatory and legal
frameworks, regulatory requirements, legislation, processes and procedures
· Excellent analytical and writing skills
· Effective organizational skills
· Excellent independent judgement
· Reports observations/ problems clearly and concisely and takes appropriate actions
· Demonstrated ability to identify and understand complex issues and problems
· Effective interpersonal communication skills
· Advanced PC skills including Microsoft Office, Agile, Trackwise, Litmus
· Bachelor’s degree (B.S. or B.A.) in Engineering, Science, or related
· RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred
Global Medical Device Manufacturing CompanyWhy Work Here?
Company offers Meaningful innovation, Growth and Opportunity. It's most Admired Company in Medical Products and Equipment since 2005
Company is one of the world’s leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Offering a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neuro-technology & spine products to help people lead more active and more satisfying lives
AddressLos Angeles, CA
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