Change Control Document Specialist ( NO C2C or Third Party)

Kelly Science, Engineering, Technology & Telecom; Mahwah (NJ); On-site; USD 61,992 - 75,768; Full time

Job summary

A leading staffing firm is seeking a Document/Change Management Specialist in Mahwah, NJ. This role focuses on facilitating document changes and ensuring compliance with regulatory requirements for medical devices. Candidates should have a BS in a related field and at least 3 years of experience in a regulated industry. The position offers hourly pay between $45 and $55, depending on experience, and requires active employment authorization in the USA. Please submit your resume for immediate consideration.

Qualifications

• 3+ years’ experience in a regulated industry using electronic document/change management systems preferred.
• Basic knowledge of US and International Medical Device Regulations.

Responsibilities

• Facilitate the change management process for document related changes.
• Perform administrative activities related to learning management system.
• Ensure QMS documentation reflects actual business activities.

Skills

Project Management

Problem Solving

Communication Skills

Analytical Skills

Education

BS in science, engineering, business or related discipline

Job description

Document/Change Management Specialist (NO C2C or Third Party)

Primarily responsible for facilitating document related changes in accordance with change management procedures and relevant regulatory requirements for medical devices. This role will support an implementation GO LIVE project.

• Location: Mahwah, NJ (07430)


• Pay: Negotiable depending on DIRECT-RELATED experience up to $45 - $55 an hour


• Work Authorization: Must be currently in the United States with active employment authorization documents.

Key areas of responsibility

• Facilitate the change management process for document related changes.


• Perform administrative activities related to learning management system.


• Ensure QMS documentation reflects actual business activities while remaining compliant with applicable internal and external regulatory requirements including but not limited to Site, Division, Corporate, FDA, ISO, MDD, MDR and individual country requirements.


• Drive Good Documentation Practices.


• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS and associated documentation.

Required Education, Work Experience & Related Competencies

• BS in a science, engineering, business or related discipline.


• Demonstrated Project Lead and Project Management experience


• Minimum of 3 years’ experience in a regulated industry using electronic document/change management systems preferred.


• Basic knowledge and understanding of US and International Medical Device Regulations.


• Ability to plan, organize, and implement multiple concurrent tasks.


• Strong interpersonal skills, written, oral communication and negotiations skills.


• Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.


• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.


• Basic understanding of compliance risk situations.

Important information: To be immediately considered, please send an updated version of your resume to [e-mail].