Regulatory Affairs Specialist

Drive Compliance, Deliver Impact: Regulatory Affairs Specialist - IVDR Focus

If you're a detail-driven professional with experience in regulatory affairs, quality assurance, or medical device compliance, this opportunity puts you at the center of a critical global initiative. Join an innovative life sciences organization where your expertise will support the transition to EU In Vitro Diagnostic Regulation (IVDR) standards, ensuring products meet evolving regulatory requirements while maintaining the highest level of quality and compliance.

Hours and Pay

• Pay Rate: $45.00 - $50.00 per hour
• Schedule: Full-time, 1-year assignment
• Work Arrangement: Hybrid (core onsite days Tuesday and Thursday, plus one additional onsite day of your choice)

Benefits

This opportunity includes a comprehensive benefits package designed to support your overall well-being and financial goals. Employees have access to medical, dental, and vision insurance, along with pet insurance and a 401(k) retirement savings plan. Additional offerings include a Health Savings Account (HSA), AD&D insurance, commuter and parking accounts, and an Employee Assistance Program (EAP). Employee discount programs are also available to help make everyday expenses more manageable.

Daily Responsibilities

• Support IVDR transition activities, including preparation and revision of technical files
• Ensure all technical documentation aligns with the latest templates and clearly demonstrates product performance and compliance
• Compile and maintain technical reports, validations, and test documentation within each technical file
• Participate in regular cross-functional meetings to track progress and resolve project-related questions
• Assist with labeling conversion efforts, ensuring compliance with IVDR requirements
• Maintain and update tracking logs for labeling conversions, technical files, and regulatory activities
• Coordinate updates based on manufacturing schedules, product lot numbers, and change requests
• Support the process to un-CE Mark selected products and track progress through completion
• Communicate and track regional regulatory notifications and labeling changes
• Collaborate with internal stakeholders to ensure compliance and timely project execution

Requirements

• Bachelor's degree in biochemistry, biology, medical technology, or a related field
• 3-5 years of experience in Regulatory Affairs, Quality Assurance, R&D, Manufacturing, or Project Management within the IVD industry
• Strong understanding of regulatory processes and documentation standards
• Ability to work both independently and collaboratively in a cross-functional environment
• Excellent communication, analytical, and problem-solving skills
• Strong attention to detail and ability to manage multiple priorities

Preferred Qualifications

• Knowledge of FDA regulations and CE marking requirements for IVD products

This is a unique opportunity to contribute to global regulatory compliance, medical device standards, and product lifecycle management, playing a key role in ensuring safe and effective products reach the market.

Click Apply Now to connect with our recruiting team and take the next step in your regulatory affairs career.

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