Know ATS Score
CV/Résumé Score
  • Expertini Resume Scoring: Our Semantic Matching Algorithm evaluates your CV/Résumé before you apply for this job role: Regulatory Affairs Manager.
United States Jobs Expertini

Urgent! Regulatory Affairs Manager Job Opening In Omaha – Now Hiring Katalyst HealthCares & Life Sciences

Regulatory Affairs Manager



Job description


Responsibilities:

  • The Regulatory Affairs Manager is responsible and accountable for Company Core Data Sheets (CCDS), Company Core Safety Information (CCSI) and Reference Safety Information (RSI for assigned products, including regulatory responsibilities in associated change control and labeling processes.

  • This person is instrumental in the design, development, and maintenance of global regulatory processes and business solutions.

  • This is a meaningful individual contributor who will partner with key business, functional and business partners to ensure commercial objectives are achieved.

  • Accountable for all operational aspects including owning, creating, and/or maintaining CCDS/CCSI/RSI documentation, delivering, maintaining, and driving regulatory systems, databases, and labeling processes that support therapeutic and combination products.

  • Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled process and systems workflows; lead reviews and manage the documents through approvals and governance by cross-functional executive and subject matter authority leadership.

  • Make decisions regarding patient safety signals, indications, risk and other sophisticated change or regulated content creation/modification triggers.

  • Support global implementation of CCDS/CCSI/RSI into country-specific labeling by developing and approving implementation of complex global and local labeling and other regulated solutions in accordance with the end-to-end regulated content, labeling processes, and commercial objectives, including reviewing deviations, exemptions, and deferrals.

  • Participate in the execution of regulatory labeling and content strategies for new products and ongoing compliance for products already on the market, including monitoring, evaluating, and internally communicating new and existing applicable regulatory requirements.

  • Lead or support global technology, process, and solution initiatives to standardize, and enable standard process in labeling and content management, including requirements, use cases and translations.

  • Deliver responses, solutions, and find opportunities to improve based upon quality initiatives, including audits and risk mitigation.

  • Perform gap analysis on regulated content management processes; design, develop, assess, improve, implement, and maintain associated complex and simple Global Regulatory Affairs and Quality processes and business solutions.

  • Requirements:
  • BS/MS degree or equivalent experience required.

  • Expertise with global medical device regulations and registration processes, especially USA (k) and EU MDR.

  • Superior presentation skills when communicating with all levels of the organization, business partners, and external sources.

  • Ability to work with evolving technologies, systems, and global teams in a fast-paced, matrixed environment.

  • Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.



  • Required Skill Profession

    Other Management Occupations



    Your Complete Job Search Toolkit

    ✨ Smart • Intelligent • Private • Secure

    Start Using Our Tools

    Join thousands of professionals who've advanced their careers with our platform

    Rate or Report This Job
    If you feel this job is inaccurate or spam kindly report to us using below form.
    Please Note: This is NOT a job application form.


      Unlock Your Regulatory Affairs Potential: Insight & Career Growth Guide


    • Real-time Regulatory Affairs Jobs Trends in Omaha, United States (Graphical Representation)

      Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Regulatory Affairs in Omaha, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 4436 jobs in United States and 14 jobs in Omaha. This comprehensive analysis highlights market share and opportunities for professionals in Regulatory Affairs roles. These dynamic trends provide a better understanding of the job market landscape in these regions.

    • Are You Looking for Regulatory Affairs Manager Job?

      Great news! is currently hiring and seeking a Regulatory Affairs Manager to join their team. Feel free to download the job details.

      Wait no longer! Are you also interested in exploring similar jobs? Search now: .

    • The Work Culture

      An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Katalyst HealthCares & Life Sciences adheres to the cultural norms as outlined by Expertini.

      The fundamental ethical values are:
      • 1. Independence
      • 2. Loyalty
      • 3. Impartiality
      • 4. Integrity
      • 5. Accountability
      • 6. Respect for human rights
      • 7. Obeying United States laws and regulations
    • What Is the Average Salary Range for Regulatory Affairs Manager Positions?

      The average salary range for a varies, but the pay scale is rated "Standard" in Omaha. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.

    • What Are the Key Qualifications for Regulatory Affairs Manager?

      Key qualifications for Regulatory Affairs Manager typically include Other Management Occupations and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.

    • How Can I Improve My Chances of Getting Hired for Regulatory Affairs Manager?

      To improve your chances of getting hired for Regulatory Affairs Manager, consider enhancing your skills. Check your CV/Résumé Score with our free Tool. We have an in-built Resume Scoring tool that gives you the matching score for each job based on your CV/Résumé once it is uploaded. This can help you align your CV/Résumé according to the job requirements and enhance your skills if needed.

    • Interview Tips for Regulatory Affairs Manager Job Success
      Katalyst HealthCares & Life Sciences interview tips for Regulatory Affairs Manager

      Here are some tips to help you prepare for and ace your job interview:

      Before the Interview:
      • Research: Learn about the Katalyst HealthCares & Life Sciences's mission, values, products, and the specific job requirements and get further information about
      • Other Openings
      • Practice: Prepare answers to common interview questions and rehearse using the STAR method (Situation, Task, Action, Result) to showcase your skills and experiences.
      • Dress Professionally: Choose attire appropriate for the company culture.
      • Prepare Questions: Show your interest by having thoughtful questions for the interviewer.
      • Plan Your Commute: Allow ample time to arrive on time and avoid feeling rushed.
      During the Interview:
      • Be Punctual: Arrive on time to demonstrate professionalism and respect.
      • Make a Great First Impression: Greet the interviewer with a handshake, smile, and eye contact.
      • Confidence and Enthusiasm: Project a positive attitude and show your genuine interest in the opportunity.
      • Answer Thoughtfully: Listen carefully, take a moment to formulate clear and concise responses. Highlight relevant skills and experiences using the STAR method.
      • Ask Prepared Questions: Demonstrate curiosity and engagement with the role and company.
      • Follow Up: Send a thank-you email to the interviewer within 24 hours.
      Additional Tips:
      • Be Yourself: Let your personality shine through while maintaining professionalism.
      • Be Honest: Don't exaggerate your skills or experience.
      • Be Positive: Focus on your strengths and accomplishments.
      • Body Language: Maintain good posture, avoid fidgeting, and make eye contact.
      • Turn Off Phone: Avoid distractions during the interview.
      Final Thought:

      To prepare for your Regulatory Affairs Manager interview at Katalyst HealthCares & Life Sciences, research the company, understand the job requirements, and practice common interview questions.

      Highlight your leadership skills, achievements, and strategic thinking abilities. Be prepared to discuss your experience with HR, including your approach to meeting targets as a team player. Additionally, review the Katalyst HealthCares & Life Sciences's products or services and be prepared to discuss how you can contribute to their success.

      By following these tips, you can increase your chances of making a positive impression and landing the job!

    • How to Set Up Job Alerts for Regulatory Affairs Manager Positions

      Setting up job alerts for Regulatory Affairs Manager is easy with United States Jobs Expertini. Simply visit our job alerts page here, enter your preferred job title and location, and choose how often you want to receive notifications. You'll get the latest job openings sent directly to your email for FREE!