Regulatory Specialist

18 Nov, 2020

Jobs

Regulatory Specialist

Karl Storz
El Segundo, CA

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 70 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.

KARL STORZ Endoscopy-America, Inc. 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.

 

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-NM1

Working at KARL STORZ during COVID-19
KARL STORZ will continue to maintain a safe work environment for our employees. During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking. The impact and/or company-issued personal protection equipment may vary based on the nature and location of the role. Please click here to learn more about our 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 Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. KARL STORZ is an Equal Opportunity Employer supporting EOE/M/F/Vet/Disability.

Reasonable Accommodation
If, at any point in the application process (including hiring), a candidate would like to request a reasonable accommodation due to a disability or a religious need, please email us at Taleo_Administrator@karlstorz.com and we’ll be happy to engage in an interactive process with you.

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.

Learn more here

Job posted: 2020-11-18