Job Title:
Regulatory Specialist II

Location:
South Portland,ME 04074

Duration:
12 Months Contract

Work Type:
Onsite

Job Summary:
The Regulatory Specialist II supports global regulatory activities for in vitro diagnostic medical devices. This role is responsible for preparing and maintaining European Union technical documentation and supporting international product registrations. The position collaborates closely with product development and regional regulatory teams to ensure compliance with applicable regulations and quality system requirements.

Key Responsibilities:
• Prepare and author technical documentation in accordance with In Vitro Diagnostic Medical Device Regulation requirements
• Provide regulatory support for diagnostic products in development and for commercially marketed products
• Develop regulatory strategies to support product approvals, clearances, and modifications in the European Union and international markets
• Support regional regulatory teams with submissions, renewals, and license amendments
• Research and interpret scientific and regulatory information to support submission development
• Compile, publish, and maintain submission dossiers, registrations, and marketing authorizations
• Assess product, manufacturing, and labeling changes for regulatory impact and compliance
• Develop internal regulatory procedures, tools, and guidance documents
• Conduct informational and training sessions for cross-functional stakeholders
• Maintain organized electronic and physical regulatory records in alignment with quality system requirements

Required Qualifications:
• Bachelor’s degree in biology, chemistry, biochemistry, engineering, or a related technical field, or equivalent experience
• Four or more years of experience in a regulatory affairs role
• Strong knowledge of European Union regulatory requirements, including In Vitro Diagnostic Medical Device Regulation
• Experience preparing technical files and regulatory submissions
• Excellent written and verbal communication skills
• Ability to manage multiple projects and work independently or within a team

Preferred Qualifications:
• Experience working in an in vitro diagnostic or medical device manufacturing environment
• Familiarity with international regulatory submission processes
• Experience supporting quality management systems aligned with international standards

Benefits:
This is a direct hire opportunity. The selected candidate will be employed directly by the company. All compensation and benefits, including but not limited to medical insurance, retirement plans, paid time off, and other perks, will be provided by the company in accordance with internal policies and applicable laws and eligibility requirements.

Pay Range:
Pay Range: $30 – $40 per hour