Regulatory Affairs Specialist

Job Description

Job Description

Job Summary :

The Regulatory Affairs Specialist is an individual contributor and subject-matter expert responsible for developing and executing regulatory strategies for post-market activities within the Hematology Regulatory Affairs team. This role focuses on evaluating, coordinating, and implementing post-market regulatory activities, managing design change evaluations, and ensuring compliance with applicable global regulations. The position also supports regulatory strategy for new product development submissions and registrations. Reporting to the Director of Regulatory Affairs, the incumbent will collaborate cross-functionally and with third parties to ensure compliance, manage IVDR Technical Files, and support changes to legal manufacturer designations for Beckman products.

Key Responsibilities :

• Manage and maintain IVDR Technical Files in full compliance with applicable EU regulatory requirements.
• Evaluate, prepare, and execute regulatory strategies for post-market activities and design changes.
• Advise business teams on the impact of regulatory issues and ensure alignment with corporate risk posture.
• Develop and execute regulatory strategies for new product development and relevant submissions or registrations.
• Ensure timely completion of Health Canada and EU submissions, including registration and post-market notifications.
• Provide regulatory leadership for design change teams, ensuring all applicable requirements are addressed.
• Collaborate globally to maintain consistent regulatory practices and processes across regions.
• Minimize post-market submission risks and agency review delays through effective planning and communication.

Required Skills :

Preferred Skills :

Education :

Bachelor’s or Master’s degree in Life Sciences or a related field.

Company Description

Compunnel Inc., established in 1994; is a leading provider of Staffing, IT / Software, e-Learning / Training, Business Intelligence, and Cloud Solutions. A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based / SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments. Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia. As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.

We have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year. Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US. We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national / ethnic region, disability, or any other basis.

Company Description

Compunnel Inc., established in 1994; is a leading provider of Staffing, IT / Software, e-Learning / Training, Business Intelligence, and Cloud Solutions. A leader in contingent and permanent workforce solutions, we also provide temp-to-hire staffing, project-based / SOW staffing, and payroll services to our esteemed clientele which includes Fortune 500 companies of diverse industry segments. Ranked as one of the largest staffing firms in the US which is our primary service market; we also have a significant presence in Europe and Asia. As a national service provider in the US, we are serving our customers all major states and regions; thereby generating numerous job opportunities for prospective employees in their preferred locations of choice.\r\n\r\nWe have witnessed multi-fold YOY growth, and continuously adding a large pool of talented resources to our employee base every year. Our extensive experience in hiring professionals of multiple in-demand skill sets (IT, Engineering, Healthcare, Admin-Clerical, Finance, Professional, Light Industrial, etc.) further makes Compunnel a wider and preferred platform for people to pursue their careers in the US. We welcome people from all walks of life and cultures, and we support workforce diversity by providing equal employment opportunities to people without any discrimination based on race, color, gender, religion, national / ethnic region, disability, or any other basis.