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Associate Specialist, Technical Writing - Quality Laboratories

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 10, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Associate Specialist, Technical Writing - Quality Laboratories USA - California - Irvine The Associate Technical Writer will be an important member of the Edwards Quality Biology Laboratories. They will primarily assist the biocompatibility team with developing documentation to support regulatory submissions for Edwards' devices. Responsibilities for this position include: Provide technical writing support for the generation of biological safety assessments based upon Good Laboratory Practices (GLP) protocols and reports, technical summaries, clinical instructions for use (IFUs) and chemical characterization reports for domestic and international regulatory submissions. Assist in interfacing with stakeholders (e.g, laboratory technicians, engineers, project teams, regulatory teams and management) to develop an understanding of the product, component, or device changes and gain consensus with authors to make appropriate adjustment to documents Generate and maintain documentation in a standard template format following established guidelines. Generate formatted tabular data summaries to facilitate the development of toxicological risk assessments. Support the maintenance of a library of risk summaries to support medical device risk evaluations. Perform quality control (QC) checks of draft documents to ensure the accuracy of the data and resulting subsequent conclusions. Review documents for style, clarity, grammar, and punctuation. Ensure compliance with department and company procedures. Other duties assigned by Leadership QUALIFICATIONS
Education and Minimum Requirements: Bachelor's degree in science related field (Biology, Chemistry preferred) and 1 + year of technical writing experience in the medical device, pharmaceutical, biotechnology or other highly regulated life sciences industry Preferred Qualifications: Prior technical writing experience for Quality Assurance or Regulatory Affairs in the medical device industry Additional Talents and General Expectations: Good technical writing skills Good editing and proofreading skills Good computer skills in Microsoft Office Suite including Word, Excel, Powerpoint, Adobe Good written and verbal communication skills in English Good problem-solving and critical thinking skills Good knowledge and understanding of policies, procedures and guidelines relevant in the development of technical documentation Good knowledge of documentation (e.g, procedures, technical summaries, protocols, and test reports) Ability to manage competing priorities in a fast paced environment Must be able to work in a team environment, including immediate supervisor and other team members in the section or group Ability to build stable working relationships internally Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Full time Req-6473 About Us Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.-- For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

Keywords: Edwards Lifesciences Gruppe, Irvine , Associate Specialist, Technical Writing - Quality Laboratories, Advertising , Irvine, California

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