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Regulatory Specialist at Karl Storz Endoscopy

Posted in Compliance 30+ days ago.

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Type: Full Time
Location: El Segundo, California





Job Description:

KARL STORZ SE & Co. KG (KST), based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 70 years, KST has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ Endoscopy-America, Inc. (KSEA), an affiliate of KST, is headquartered in El Segundo, California, and is responsible for all U.S. distribution and sales of endoscopes, instruments, imaging systems, electromechanical devices, and OR1 operating room integration technologies.

What does all that mean to you*

It means you would be joining an organization where you can be proud to play a part in making a difference in people s lives every day.

Being a part of KARL STORZ offers many additional rewards.

This includes a commitment to offering Competitive compensation, as well as a 401(k) with a 60% match up to the first 6% of your base salary.

We support our employees health goals by providing Outstanding health benefits that include, but are not limited to, Medical (PPO, HRA, HSA, and flex spending), Dental and vision, as well as amazing Wellness programs where you can earn cash or gift cards.

We encourage work/life balance so our employees can Recharge and take care of themselves. We offer new employees 3 weeks of paid vacation in the first year, 10 paid holidays and Paid sick leave that can also be used to take care of immediate family members.*

We strive to continuously Learn and give back to our community. We offer our employees the same opportunity through Tuition reimbursement, multiple Company-sponsored charitable events and Corporate matching for charitable giving.

If KARL STORZ sounds like a company you would like to be a part of, we invite you to learn about our opportunity below!

ROLE OVERVIEW

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.

KEY RESPONSIBILITIES

Key responsibilities will include, but may not be limited to:

* 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.

REQUIREMENTS

Our successful candidate will have excellent written and spoken English language business communication skills. They will also have demonstrated success working in a collaborative, service-oriented team environment.

Additional requirements include, but are not limited to:

* 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

*Field sales, internships and part-time employees are not eligible for paid time off except for where required by state law.