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Associate Regulatory Affairs Specialist

Company: Disability Solutions
Location: El Segundo
Posted on: June 9, 2024

Job Description:

KARL STORZ is currently recruiting for an Associate Regulatory Affairs Specialist who will be responsible for assisting the US Regulatory Affairs Team in preparing, organizing, and maintaining documentation required for regulatory compliance. This position also assists in communicating product clearance information to other departments within the organization and to external distributors and agencies. Responsibilities

  • To be knowledgeable at all times of current and emerging regulatory requirements affecting the business regarding actions necessary to obtain or maintain compliance with applicable regulations.
  • Report to Senior Manager, Regulatory Affairs on the performance of Regulatory items.
  • To regularly survey the Regulatory environment, and provide communication and special reports as necessary, to ensure that the company remains aware of significant events or issues which could have a substantial effect (positive or negative) on it.
  • Maintain high levels of work and accountability.
  • Help define strategy and provides guidance and support on regulatory requirements to new product development and sustaining projects from initial kick-off to post-marketing phase for US and Canada markets.
  • Assist and support FDA and Health Canada submissions of simple complexity through to clearance/approvals.
  • Reviews and approves engineering change orders.
  • Participate in research and resolution of regulatory issues. Disseminates regulatory information to Production, QA, QC and R&D departments and senior management, as required.
  • Assist in registering products in any other countries as needed.
  • Prepare briefing documents for and participate in internal regulatory meetings and meetings with regulatory authorities as necessary.
  • Other incidental duties Requirements
    • Bachelor's degree plus 1-3 years of experience in a highly regulated industry; or 0-1 year of experience with Master's degree in Regulatory
    • Excellent problem-solving, organizational, analytical and critical thinking skill
    • Demonstrates initiative to organizational and process improvements.
    • Ability to manage multiple projects from start to completion.
    • Solid PC skills (MS Office Suite, etc.)
    • Excellent communication skills
    • Exceptional organizational skills
    • Strong attention to detail
    • Ability to manage competing priorities in a fast-paced environment.
    • Eagerness to learn
    • Demonstrated experience building strategic partnerships to further departmental and organizational objective.
    • Ability to travel up to 25% Preferences
      • 3+ years of experience in a highly regulated industry or within KS organization
      • Bachelor degree or higher in scientific or engineering field or in regulatory affairs discipline.
      • Hands on experience using SAP LI-CW1Your 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**
        • 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
        • Employee referral program of up to $2,000 per hire
        • And much more! *Field sales, internships, and part-time employees are not eligible except where required by state law. Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program. **To include, maternal/paternal leave, adoption, and fostering of a child. 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, Los Angeles , Associate Regulatory Affairs Specialist, Other , El Segundo, California

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