This job listing has expired and the position may no longer be open for hire.

Senior Regulatory Affairs Specialist - El Segundo, CA at Karl Storz Endoscopy

Posted in Compliance 30+ days ago.

Type: Part Time
Location: El Segundo, California





Job Description:

Company: KARL STORZ North America (KSNA)

Job Code: 10712

Pay Grade: US-C16

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.

Job Function:

- Acts as a regulatory representative to the site and provides guidance and expertise on regulatory requirements.

- Perform regulatory submission assessments for new and changes/modifications made to a cleared 510(k) or PMA device(s). This includes design and manufacturing changes.

- Manage FDA submissions (i.e. 510(k), PMA, Annual Report, PMA Supplement, notification, etc.) through to completion by tracking its review progress at FDA and coordinating any response to FDA requests for further information.

- Supports and provides regulatory expertise to assigned medical device new product development and sustaining projects from initial kick-off to post-marketing phase.

- Reviews and approves engineering change orders.

- Prepare submissions for Canadian Licenses and respond to any information requests from Heath Canada.

- Assist in registering products in any other countries as needed.

- Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management, as required.

- Lead implementation of Regulatory Affairs policies, programs, and procedures.

- Prepare briefing documents for and participate in internal regulatory meetings and meetings with regulatory authorities as necessary.

- Anticipate and advise on future regulatory trends and direction and recommend preemptive approaches for company regulatory compliance.

Qualifications:

- A minimum education level of a bachelor degree or higher in engineering or scientific field.

- At least 5 years of US Regulatory submission experience with a medical

- Possess exceptional organizational skills and the ability to multi-task.

- Ability to identify and solve problems and work independently with little oversight.

- History of successful 510(k)/IDE/PMA device/supplement submissions.

- 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 STRONG written and oral communication skills and solid PC skills (MS Office Suite, etc.)

- Ability to work as part of a team.

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-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 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.

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