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, Huntington Park , Associate Regulatory Affairs Specialist, Labeling, Other , El Segundo, California