Regulatory Operations Assistant I

Job Overview:

Responsible for Quality Risk Management activities for combination products by assisting with risk assessments technical documentation compliance reviews and CAPA initiatives. Collaborate with cross-functional teams to ensure product quality regulatory compliance and continuous improvement throughout the product lifecycle.

Summary of Responsibilities:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities skills and duties as individual contributor globally.

• Support the team in implementing risk management processes procedures and documentation required for the Quality Risk Management program. Focus will be on combination products used in surgical procedures; therefore an understanding of surgical procedures would be beneficial.

• Assist in providing quality support for new combination product development activities and lifecycle management.

• Prepare and contribute to technical reports in compliance with cGMP requirements.

• Collaborate with stakeholders and business partners to identify improvement opportunities and support the achievement of project goals and objectives. (This role may require participation in calls/meetings during US business hours.)

• Contribute to data-driven risk assessments including risk identification analysis and evaluation and support the development of risk mitigation and CAPA plans.

• Perform assigned activities in accordance with Standard Operating Procedures (SOPs).

• Support the coordination and maintenance of documents within the document management system.

• Assist in ensuring compliance with procedures and customer requirements.

• Help identify potential issues support troubleshooting activities assist in resolving documentation-related challenges and coordinate issue resolution in a timely manner.

• Qualifications (Minimum Required):

• Bachelors in Engineering life science or related Health science degree (or equivalent); OR Advanced Degree (e.g. PhD or Masters) as applicable. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Speaking-English and/or other languages as applicable

• Experience (Minimum Required):

• 0-1 Years of experience in the job discipline (e.g. Medical Devices Regulatory Affairs/Quality Assurance/Analytical science / Formulation science / material management and overall drug development and manufacturing process.)
• Technical proficiency with Microsoft Office suite of applications/ Document Management and/or publishing tools.
• Good understanding of the pharmaceutical product life cycle and regulatory requirements GxP and ICH-GCP guidelines desirable
• Interpersonal skills Proactive Taking ownership Precise Goal oriented.
• Good organizational and time management ability
• Good analytical capabilities and Customer focus
• Good review skills and concern for quality

• Preferred Qualifications Include:

• Bachelors in pharmacy or related science degree (or equivalent); OR Advanced Degree (e.g. PhD or Masters) with 0-1 years of relevant experience. Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
• Knowledge of Management Information System (MIS) and electronic data management system(eg: Regulatory Information Management etc.) will be preferred
• Diploma or Certification in Regulatory Affairs will be preferred

• Physical Demands / Work Environment:

• Physical demands: No special factor at this time
• Work environment: Office environment or remote

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