Regulatory Affairs Specialist

Job Description

Job Description

JOB SUMMARY

The Regulatory Affairs Specialist is responsible for leading and supporting global regulatory submissions, technical documentation, and international regulatory filings for new and modified medical devices. This role develops and executes global regulatory strategies, manages submission activities to meet product launch timelines, and ensures ongoing compliance with global regulations. The specialist also provides guidance, training, and support to cross-functional teams and engages with regulatory authorities as required.

KEY RESPONSIBILITIES

• Support regional regulatory colleagues in preparing international submissions for new and modified devices.
• Act as the Regulatory Affairs lead on project teams to develop strategies, testing requirements, and documentation aligned with launch timelines.
• Manage and lead regulatory-driven projects as directed by management.
• Develop and execute global regulatory strategies to support new product launches and market expansion.
• Maintain up-to-date knowledge of global regulations, standards, guidance documents, and country-specific requirements.
• Plan, lead, and support internal and external regulatory audits.
• Directly engage with regulatory authorities as needed.
• Initiate and manage regulatory change assessments (e.g., design, labeling, manufacturing, process changes) and update registrations as required.
• Develop and maintain company SOPs to ensure compliance with global regulatory requirements.
• Provide regulatory guidance, training, and mentoring to other RA employees and cross-functional teams.
• Review product labeling for compliance with applicable regulations.
• Perform other assigned duties as required.

REQUIRED QUALIFICATIONS

PREFERRED QUALIFICATIONS

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.