Regulatory Affairs Specialist II

Job Title: Regulatory Affairs Specialist II

Location: South Portland, ME

Duration: 12 Months

**Onsite Interview**

Position Summary

The Regulatory Affairs Specialist II is responsible for supporting global regulatory activities for diagnostic products, with a strong focus on EU Technical File preparation and international product registrations. This role ensures compliance with applicable regulations, including IVDR, and supports product lifecycle regulatory strategies.

Key Responsibilities

• Prepare and maintain EU Technical Files in compliance with IVDR requirements.
• Author, compile, and review regulatory submission documents for EU and international markets.
• Develop and execute regulatory strategies for new product development and product modifications.
• Provide regulatory support for both development-stage and commercial diagnostic products.
• Collaborate with regional regulatory teams on submissions, license renewals, and amendments.
• Research and interpret scientific and regulatory information to support submissions.
• Maintain and track regulatory approvals, licenses, and authorizations.
• Assess the regulatory impact of product, manufacturing, and labeling changes.
• Support compliance with global regulatory requirements and internal quality standards.
• Develop and improve internal regulatory procedures, tools, and documentation processes.
• Conduct training sessions and provide regulatory guidance to cross-functional teams.
• Organize and maintain regulatory documentation (electronic and hard copy systems).
• Ensure adherence to Quality Management Systems in line with ISO, FDA, and other regulatory bodies.
• Maintain professional communication with internal and external stakeholders.

Basic Qualifications

• Bachelor’s degree in Biology, Chemistry, Biochemistry, Engineering, or a related technical field.
• Minimum 4 years of experience in Regulatory Affairs.
• Strong knowledge of EU IVDR and regulatory requirements.

Preferred Qualifications

• Experience in IVD or medical device manufacturing environments.
• Exposure to international regulatory submissions outside the EU.

Core Competencies

• Solid understanding of EU and global regulatory frameworks.
• Strong technical writing and documentation skills.
• Effective verbal and written communication abilities.
• Excellent time management and multitasking skills.
• Ability to work both independently and collaboratively.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Visio).