Regulatory Specialist - United States
KARL Storz (company)
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.
- 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.ealth 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.
- A minimum education level of a(n)
- 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.
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.