Regulatory Affairs Specialist

Job Description

Regulatory Affairs Specialist | United Consulting Hub

The Tone:
This is a contract role at United Consulting Hub, located remotely. United Consulting Hub is seeking a motivated entry-level specialist to support crucial regulatory compliance and documentation within a regulated pharmaceutical or medical device environment. This role is essential for assisting with regulatory submissions, maintaining product documentation, and ensuring compliance through collaboration with various internal teams.

The TL;DR
• Role: Contract / Early Career
• Type: Contract
• Location: Remote

• Mission: This person supports regulatory compliance and documentation for pharmaceutical and medical device products.
• Tech Stack: Document management systems

What You’ll Actually Do
• Manage Submissions: Support the preparation, maintenance, and submission of critical regulatory documentation, including product registrations and regulatory filings.
• Ensure Compliance: Facilitate ongoing compliance with FDA, ISO, and global regulatory requirements, while also reviewing and maintaining technical files, SOPs, and quality documentation.
• Collaborate Cross-functionally: Work closely with Quality, Engineering, Clinical, and Manufacturing teams to integrate and support regulatory needs.
• Update Documentation: Assist with change control processes, updating product labeling, and ensuring product documentation remains current.
• Maintain Records: Organize and meticulously maintain accurate and comprehensive regulatory records, contributing to audit and inspection readiness.

The Must-Haves
• Background: Hold a Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a closely related scientific or engineering field. This role requires a foundational understanding of the principles governing regulated industries.
• Experience: Possess 0–2 years of relevant experience within Regulatory Affairs or a regulated industry environment, with a demonstrated capacity for strong documentation practices.
• Skills: Exhibit a basic understanding of key regulatory frameworks, including FDA Regulations, GMP/cGMP, and ISO 13485 standards, particularly within medical device or pharmaceutical regulatory processes. Strong communication and organizational skills are essential, coupled with the ability to effectively collaborate within cross-functional team settings.
• Bonus: Prior exposure to medical device or pharmaceutical environments, familiarity with regulatory submissions and technical documentation, knowledge of labeling, change control, or quality systems, and experience with document management systems are all highly valued.