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Technical Writer - Regulatory Affairs

Expired Job

Karl Storz Endovision Inc El Segundo , CA 90245

Posted 4 months ago

For more than 70 years, KARL STORZ has established itself as a Minimally Invasive Surgical company that provides superior endoscopic imaging, enabling surgeons to better visualize anatomy and ultimately provide better surgical outcomes to patients. Our technologies include companion instrumentation and cover virtually every specialty from head to toe. We are a market leader in operating room integration setting the standard for technological advancement with superior image management solutions. Our commitment to advancing visionary ideas has helped launch numerous MIS procedures, including many that are exclusive to KARL STORZ. As a leader in supporting education and training as well as humanitarian causes, our company continues to distinguish itself as a privately held, family-owned and operated business.

Headquartered in El Segundo, California, KARL STORZ Endoscopy-America is responsible for all U.S. distribution of endoscopes, instruments, imaging systems, electromechanical devices and OR1 integration technologies.

The RA Technical Writer will write and revise user manuals, instructions for use, and related user product instructions for medical devices and equipment; interview subject matter experts; research and analyze product documentation and clearly present findings; ensure consistency between user product instructions. The Writer will also keep track of comments made in meetings and emails about content of user product instructions and be able to retrieve that information in the future.

REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:

  • 3+ years of relevant experience or equivalent combination of education and work experience.

  • Expert knowledge of advanced features of Microsoft Word

  • Proficient in Microsoft Excel

  • Proficient in Adobe Acrobat; InDesign a plus.

  • Familiar with PowerPoint, Visio, and One2Edit software.

  • Familiar with document management systems.

  • Experience working with regulated medical documentation.

REQUIRED KNOWLEDGE AND SKILLS:

  • Able to interview all levels of subject matter experts to obtain the appropriate information needed for user product documentation

  • Able to write documentation in a manner that users with limited to highly proficient technical product knowledge can understand.

  • Excellent English, spelling, and grammar skills and able to write clear, concise instructions in a logical sequence.

  • Able to review and edit content to ensure consistency and compliance with internal style guides, trademark usage, and other documentation standards

  • Able to write for translatability.

  • Able to develop new documentation that is similar to existing documentation and able to recommend entirely new documentation layouts

  • Able to manage and meet multiple project deliverables and deadlines

  • Well organized, thorough, and detailed oriented

  • Good research, information gathering, and analytical skills

  • Able to adapt to a fast-paced, changing environment

  • Able to analyze project scope, setting interim deadlines for documentation development.

  • Able to work independently and manage time effectively

  • Able to make decisions, exhibit sound and accurate judgment, support and explain the reasoning for decisions, and include the appropriate people in the decision-making process

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employee must comply will all applicable KARL STORZ policies and procedures.

KSEA provides equal employment opportunities (EEO) to all applicants without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, KSEA complies with applicable state and local laws governing non-discrimination in employment.


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Karl Storz Endovision Inc

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VIEW JOBS 12/6/2018 12:00:00 AM 2019-03-06T00:00 KARL STORZ Endoscopy-America, Inc. (KSEA), is an affiliate of KARL STORZ GmbH & Co. KG, an international leader for more than 70 years in reusable endoscope technology, encompassing all endoscopic specialties. Based in Tuttlingen, Germany, KARL STORZ GmbH & Co. KG is a family-owned company that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship and clinical effectiveness. Headquartered in El Segundo, California, KSEA is responsible for all U.S. distribution of endoscopes, instruments, imaging systems, electromechanical devices and OR1® integration technologies. KSEA as a Relabeler/ Repackager of medical devices manufactured by KST and is regulated by the FDA in the United States, and similar bodies in other countries. In order to market and sell KS products, we must comply with all applicable regulations in each country in which the products are sold. This position is to ensure that KSEA, KSEC and KSLA comply with the United States' Federal Code of Regulations for medical devices and Health Canada: Canadian Medical Devices Regulations. We are seeking to hire in our El Segundo, CA location. The selected individual will need to work in the office five days per week. Job Function: * Perform regulatory submission assessment for changes/modifications made to a cleared 510(k) or PMA device(s) and classification assessment for new devices. * Determine regulatory requirements for changes/modifications made to the 510(k) or PMA device(s), and/or new devices to be included in the 510(k) and PMA system. * Prepare and file 510(k), PMA, HDE, Annual Report, PMA Supplement, notification, etc. based on the technical information provided by the development project team. Follow the 510(k) and PMA through to completion by tracking its review progress at FDA and coordinating any response to FDA requests for further information. * Prepare submissions for Canadian Licenses and respond to any information requests from Heath Canada. * Assist in registering products in the United States, Canada, and any other countries as needed. * Obtain Certificate for Foreign Government and other notarized documents as required to support worldwide submissions. * Review and provide input to Marketing on the approval of marketing literature to ensure compliance with FDA cleared or approved claims and other applicable regulations. * Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management, as required. Qualifications: * A minimum education level of a bachelor degree or higher in engineering or scientific field. * 2 to 4 years of experience, in a similar role with a medical device company (outside of Karl Storz). Alternatively, a minimum of 1 year performing a similar job within Karl Storz. * Possess exceptional organizational skills and the ability to multi-task. * This individual should have experience in dealing with the FDA & should be familiar with FDA regulations, guidelines, and requirements as well as other medical device related regulations (GMP, GSR). * Must possess excellent written and oral communication skills and solid PC skills (MS Office Suite, etc.) * Knowledge of relevant sections of the Code of Federal Regulation pertaining to medical devices in general, and more specifically, to premarket notifications and premarket approvals. * Ability to identify and solve problems and work independently with little oversight. #LI-MN1 Karl Storz reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship. Additionally, Karl Storz, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employee must comply will all applicable Karl Storz policies and procedures . KSEA provides equal employment opportunities (EEO) to all applicants without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, KSEA complies with applicable state and local laws governing non-discrimination in employment. #LI-MN1 Karl Storz Endovision Inc El Segundo CA

Technical Writer - Regulatory Affairs

Expired Job

Karl Storz Endovision Inc