Data Solutions Coordinator (Regulatory Intelligence)

About the Company

Redica Systems is a data analytics start-up serving over 200 customers in the life sciences sector, with a particular focus on Pharmaceuticals and MedTech. Our team is distributed globally, with headquarters in Pleasanton, CA. Redica’s platform empowers companies to enhance product quality and stay ahead of evolving regulations. Using proprietary processes, we leverage one of the industry’s most comprehensive datasets, sourced from hundreds of health agencies and FOIA records. Our customers use Redica Systems to more effectively and efficiently manage their inspection preparation, monitor their supplier quality, and perform regulatory surveillance. More information is available at redica.com.

About the Role

As a Data Solutions Coordinator on the Regulatory Intelligence team at Redica Systems, you will play a critical role in monitoring and analyzing the global regulatory landscape within the life sciences industry. Your primary responsibility will be to support our regulatory intelligence products and services by actively participating in global monitoring, surveillance, and data acquisition activities. You will work closely with cross-functional teams to identify emerging trends in the pharmaceutical and MedTech regulatory environments and ensure the accuracy and integrity of our regulatory data. This role is ideal for someone passionate about regulatory affairs who enjoys diving deep into data and thrives in a collaborative, fast-paced environment. If you are driven by the opportunity to make a significant impact in a high-growth company and are eager to contribute to our mission of helping companies navigate complex regulatory landscapes, we want to hear from you!

Responsibilities

• Actively participate in global regulatory intelligence activities, including monitoring, acquiring, tracking and categorizing information related to the evolving global regulatory landscape within the life sciences industry.
• Maintain a thorough awareness of all current and relevant regulations, guidelines, policies, procedures, and practices.
• Utilize a strong understanding of GXP to proactively identify, categorize, and analyze regulations, rules, and guidance document changes.
• Collaborate with teams to identify and assess emerging trends in the pharmaceutical and medtech regulatory environments.
• Conduct data quality checks to ensure the accuracy, completeness, and integrity of regulatory data.
• Monitor and report on key performance indicator (KPI) metrics related to regulatory activities.
• Ensure that all data acquisition and processing processes are clearly defined and consistently followed, while also recommending and implementing improvements where necessary.

Qualifications

• 2-4 years of experience in the pharmaceutical or medical device industries, with a focus on regulatory affairs or quality assurance.
• A Master’s degree (M.S.) in Regulatory Affairs or Quality Assurance is preferred.

Required Skills

• Communicates Effectively:

  Develops and delivers clear, concise communications across multiple platforms, ensuring accurate and timely sharing of regulatory intelligence insights, updates, and trends with teams and stakeholders.

• Decision Quality:

  Analyze and evaluate regulatory data, rules, and guidance document changes to make informed, timely decisions that drive forward the organization’s regulatory intelligence activities.

• Plans and Aligns:

  Organize and prioritize multiple time-sensitive projects related to monitoring, tracking, and categorizing global regulatory information, maintaining a high level of attention to detail to ensure data accuracy and relevance.

• Nimble Learning:

  Demonstrate a commitment to continuous learning by staying updated on the evolving global regulatory landscape, using new insights to improve regulatory intelligence processes and outcomes.

• Tech Savvy:

  Leverage digital tools and technology solutions to monitor regulatory changes, ensuring data accuracy and integrity while contributing to the company’s digital transformation and innovation in regulatory intelligence.

• Engaged:

  You share our values and possess the essential competencies needed to thrive at Redica, as outlined here.

Additional Information

It’s a dynamic role blending regulatory expertise with data management and process improvement in a tech-forward environment. We offer competitive salaries, comprehensive benefits packages, and a dynamic team where you can grow and develop your skills. Top Pharma Companies, Food Manufacturers, MedTech Companies, and Service firms from around the globe rely on Redica Systems to mine and process government inspection, enforcement, and registration data in order to quantify risk signals about their suppliers, identify market opportunities, benchmark against their peers, and prepare for the latest inspection trends. Our data and analytics have been cited by major media outlets such as MSNBC, WSJ, and the Boston Globe. We are committed to creating a diverse and inclusive workplace where everyone feels welcomed and valued. We believe that diversity of perspectives, backgrounds, and experiences is essential to our success. We are always looking for talented individuals who can bring unique skills and perspectives to our team. All your information will be kept confidential according to EEO guidelines.