Regulatory Specialist

Job Summary

To support regulatory compliance in product development, the contract Regulatory Specialist will manage submissions, maintain relationships with device reviewers, and assist in developing regulatory strategies while working fully remotely.

Key responsibilities

• Provide Regulatory Affairs support for submissions and ongoing compliance in the product development process
• Develop and maintain relationships with device reviewers, offering guidance on regulatory pathways and submission strategies
• Prepare and submit regulatory applications, ensuring compliance of device labeling and advertising materials

Required qualifications

• BS degree with 2-4 years of related experience, or MS degree with 0-2 years of related experience
• Demonstrated background in regulatory affairs
• Proficiency in Microsoft Office suite
• Experience with regulatory management systems for archiving and managing submissions
• Familiarity with Windchill software