Regulatory Affairs Specialist

Cynet Systems • South Portland, ME

23h • Onsite

About The Position

The Regulatory Affairs Specialist I supports domestic and international product registrations for new and modified products within the Infectious Disease business unit in Scarborough, Maine. Under general guidance, the role prepares regulatory submissions and registration documents, maintains existing marketing authorizations, and supports regulatory and quality-system compliance for products and teams.

The position also supports manufacturing and operations activities involving change control, product development, documentation, labeling, and field support. It applies regulatory and technical knowledge to assigned work and helps maintain compliance with applicable site and division policies, procedures, and quality systems.

Requirements

• Bachelor's degree in Biology, Chemistry, Biochemistry, Engineering, or another related technical field, or an equivalent combination of education and experience.
• 0–2 years of regulatory experience and/or relevant industrial experience, typically in quality, product-development/support, or scientific affairs.
• Knowledge of federal regulations.
• Knowledge of regulations and standards affecting in vitro diagnostic products (IVDs) and/or biologics.
• Knowledge of Quality Management Systems under ISO, FDA, and other regulatory agencies.
• Demonstrated written and verbal communication skills.
• Strong time-management skills and ability to work on multiple projects simultaneously.
• Ability to work independently and as part of a team.
• Proficiency with Microsoft Office, including Word, Excel, PowerPoint, and Visio.

Nice To Haves

• A bachelor's degree in a technical discipline such as biology, chemistry, microbiology, immunology, or medical technology is preferred.

Responsibilities

• Compile and publish materials required for submissions, license renewals, and annual registrations.
• Research scientific and regulatory information to help prepare submission documents.
• Maintain approvals, licenses, and authorizations for existing marketing authorizations.
• Ensure compliant product shipments by maintaining applicable inclusions, spreadsheets, and related documents.
• Add and maintain information in the Global Regulatory Information Database.
• Assess product, manufacturing, and labeling changes for regulatory reporting impact and compliance.
• Organize and maintain hard-copy and electronic department files.
• Keep informed of global regulatory information.
• Assist in developing internal procedures and tools.
• Carry out duties in compliance with established business policies.
• Support the development, implementation, and effectiveness of Quality Management Systems in accordance with ISO, FDA, and other regulatory agencies.
• Implement and maintain the effectiveness of the quality system.
• Support day-to-day manufacturing and operations activities related to change control.
• Provide consultation and advice to regulatory specialists on change control and product development.
• Provide regulatory direction and interpretation for team activities.
• Interpret and apply regulatory knowledge to support products and teams.
• Prepare U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide.
• Handle regulatory activities related to documentation, labeling, and field support.
• Maintain compliance with the appropriate quality system for the medical devices supported.
• Demonstrate knowledge of and ensure compliance with site- and division-level policies and procedures.
• Exhibit professional behavior with internal and external business associates consistent with organizational policies and practices.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level