Associate Regulatory Affairs Specialist, Labeling
Company: Disability Solutions
Location: El Segundo
Posted on: October 12, 2024
Job Description:
KARL STORZ is a leading medical device company seeking an
Associate Regulatory Affairs Specialist - Labeling to join our
team.Job Summary: Ensure compliance with FDA and international
regulations for medical device labeling, promotional materials, and
documentation. Collaborate with cross-functional teams to support
new product development, submissions, and regulatory
requirements.Key Responsibilities:
- Support review of product labeling, promotional materials,
change control, and documentation for compliance with FDA
regulations (21 CFR) and international standards (ISO 13485,
CMDCAS)
- Collaborate on FDA submission preparations for new products and
product changes
- Identify country-specific requirements for product development
projects
- Maintain knowledge of developments and changes to applicable
laws, labeling regulations, and industry standards
- Support regulatory representative on project teams and provide
recommendations for compliance
- Develop and update regulatory documentation, including product
manuals, IFUs, and work instructions
- Ensure proper assignment of labeling (e.g., IFU, UDI, product
label) Requirements:
- 2+ years of experience in Regulatory Affairs, Medical Writing,
or labeling with a healthcare company
- Alternatively, 1 year of experience within KARL STORZ or a
degree in Regulatory Affairs
- Bachelor's degree in English Writing, Regulatory Affairs, or
related field
- Knowledge of:
- FDA regulations (21 CFR) pertaining to medical devices
- Quality management systems (ISO 13485)
- Canadian Medical Devices Conformity Assessment System
(CMDCAS)
- Labeling regulations and industry standards
- Excellent communication, organizational, and PC skills (MS
Office suite) Preferred Qualifications:
- Experience with medical devices and regulatory affairs
- Strong analytical and problem-solving skills
- Ability to work in a fast-paced environment WHO WE ARE: KARL
STORZ is an independent, family-owned company headquartered in
Germany's renowned MedTech manufacturing region. For 80 years,
we've pioneered the most groundbreaking innovations in endoscopic
surgery, video imaging, and OR integration to benefit patients and
healthcare providers alike.With more than 9,000 associates
worldwide and 2,600 in the US, we pride ourselves on harnessing
cutting-edge technology, precise workmanship, and unrivaled
customer support to help healthcare facilities succeed. With onsite
locations and field opportunities across the country, we attract a
diverse and talented staff. It's not just about the tools we
create-it's about the lives we change, together.Eligible Employee
Benefits
- Medical / Dental / Vision including a state-of-the-art wellness
program and pet insurance, too!
- 3 weeks vacation, 11 holidays plus paid sick time
- Up to 8 weeks of 100% paid company parental leave; includes
maternal/ paternal leave, adoption, and fostering of a child.
- 401(k) retirement savings plan providing a match of 60% of the
employee's first 6% contribution (up to IRS limits)
- Section 125 Flexible Spending Accounts
- Life, STD, LTD & LTC Insurance
- We prepay your tuition up to $5,250 per year! - Tuition
pre-imbursement
- Fitness reimbursement of up to $200 annually
- And much more! 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. Employees must comply will all applicable KARL
STORZ policies and procedures.Credentialing requirements at KARL
STORZKARL STORZ is committed to maintaining a safe work environment
for our employees and customers. Most field-based roles at KARL
STORZ require hospital credentialing/health screens as a condition
of employment. Credentialing can include required vaccinations,
health screens & other requirements as outlined by our customers.
During the interview process, we encourage you to ask how
credentialing/health screens may impact the role you are seeking
and if you require any reasonable accommodations regarding these
requirements.Pay TransparencyThe pay range and/or hourly pay rate
listed is a good faith determination of potential base compensation
that may be offered to a successful applicant for this position at
the time of this job posting and may be modified in the future.
When determining a specific team member's base salary and/or hourly
pay rate, several factors will be considered including such things
as location, specialty, service line, years of relevant experience,
education, professional credentials, internal equity, and the
amount budgeted for the role.Equal Employment Opportunity &
Reasonable Accommodation StatementKARL 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 taoperations@karlstorz.com.Get in
Contact
Keywords: Disability Solutions, Hacienda Heights , Associate Regulatory Affairs Specialist, Labeling, Other , El Segundo, California
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