Senior Regulatory Specialist

Company: KARL STORZ North America (KSNA)

Job Code: 12035

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.

Responsibilites

• Perform regulatory submission assessment for new and changes/modifications made to a cleared 510(k) or PMA device(s). This includes design and manufacturing changes.
• 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.
• 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.
• Prepare submissions for Canadian Licenses and respond to any information requests from Heath Canada.
• Assist in registering products in any other countries as needed.
• Acts as a regulatory representative to the site and provide guidance and expertise on regulatory requirements.
• 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 device company (external to KARL STORZ).
• 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.

#LI-NM1

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.