Sr Regulatory Affairs Specialist

Title: Sr Regulatory Affairs Specialist

Pay: $42.00-$49.00/hr

Location: Remote - Chicago, IL

Schedule: Standard Office Hours

Duration: 3-Month Initial Contract




The Regulatory Affairs Specialist is responsible for preparing and maintaining regulatory submissions and approvals for assigned medical device products. This role supports global regulatory activities by coordinating submissions, tracking regulatory milestones, contributing to regulatory strategy, and ensuring compliance with international regulatory requirements. The position partners with cross-functional teams to support product development, manufacturing, and registration activities.

Key Responsibilities

• Prepare regulatory submission documentation for international markets while protecting proprietary information and ensuring submission readiness.
• Coordinate and track submission timelines, regulatory milestones, and approval status for assigned products.
• Contribute to regulatory strategies and prioritize submissions in alignment with business objectives and regional requirements.
• Assess the impact of new and evolving global regulatory requirements and recommend strategies to support timely product approvals.
• Partner with cross-functional product development and manufacturing teams to provide regulatory guidance throughout the product lifecycle.
• Support resolution of regulatory issues by identifying compliant solutions and communicating recommendations to stakeholders.
• Provide guidance on international registration requirements, product changes, renewals, and labeling updates.
• Support process improvement initiatives related to regulatory operations and submission activities.
• Perform additional responsibilities as assigned.

Required Qualifications

• Bachelor's degree in Biology, Microbiology, Chemistry, or another scientific discipline (or equivalent combination of education and experience).
• 5–7 years of regulatory affairs experience within the medical device industry.
• Experience preparing and coordinating regulatory submissions for international markets.
• Working knowledge of global regulatory requirements for Class II and/or Class III medical devices.
• Understanding of regulatory requirements for new product registrations, product changes, and lifecycle management.
• Knowledge of product development processes and regulatory considerations throughout the development lifecycle.

Preferred Skills

• Coursework, seminars, or formal training related to government regulations or trade associations.
• Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.
• Strong written and verbal communication skills.
• Excellent organizational, analytical, critical thinking, and problem-solving abilities.
• Strong attention to detail and ability to manage multiple priorities in a fast-paced environment.
• Ability to collaborate effectively with cross-functional teams and stakeholders at all organizational levels.
• Demonstrated ability to build productive internal and external working relationships.
• Commitment to environmental, health, and safety (EHS) policies and workplace compliance.

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