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$15.00 - $22.31
Full-time
El Segundo, CA 90245
Updated today
Company: KARL STORZ North America (KSNA)

Job Code: 12034

Pay Grade: TBD

Description

KARL STORZ SE & Co. KG 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 75 years, KARL STORZ 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.

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.
  • 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

Vaccine requirements at KARL STORZ due to COVID-19
KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs. During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below on the process for requesting accommodation. Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations
  • Medical / Dental / Vision including a state of the art wellness program and pet insurance, too!*
  • 3 weeks' vacation, 10 holidays plus paid sick time*
  • 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
  • Section 125 Flexible Spending Accounts
  • Life, STD, LTD & LTC Insurance
  • Tuition reimbursement of up to $5,250 per year
  • Fitness reimbursement up to $200 annually
  • Employee referral program of up to $2,000 per hire
  • And much more!

*Field sales, internships and part-time employees are not eligible except for where required by state law.
Non-employees, including temporary workers and consultants, are not eligible to participate in KARL STORZ benefits program.

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.

Equal Employment Opportunity & Reasonable Accommodation Statement
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at TaleoAdministrator@karlstorz.com.

Notice to Employment Agencies
This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required. Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by KARL STORZ Human Resources department will be ineligible for referral fees.
Posting ID: 675441045 Posted: 2022-01-28 Job Title: Regulatory Specialist