Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist (Medical Device)

Duration: 12 Months (Possible extension)

Location: Remote - PST

Remote Role

Responsibilities:

• The initial phase of the role will focus on structured training to familiarize the candidate with internal systems, processes, and procedures.
• Once training is completed, the primary responsibility will involve archiving regulatory submissions to help address existing backlog.
• Upon successful completion of this phase, the individual will gradually transition into broader responsibilities aligned with the core functions of the Regulatory Specialist role.
• Responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process.
• Developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
• Assists with developing and implementing regulatory strategies for new and modified medical devices.
• Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
• Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

Education/Experience:

• BS degree and 2-4 years of related experience, or MS degree and 0-2 years of related experience
• Demonstrated background in regulatory affairs (required)
• Proficiency in Microsoft Office suite
• Experience working with regulatory management systems used for archiving and managing submissions; this will be a primary focus area of the role
• Strong written and verbal communication skills, with the ability to collaborate across multiple departments
• Must have a dedicated, professional home office environment with reliable internet connectivity to support remote work responsibilities

Preferred:

• Master’s degree in Regulatory Affairs with 0–2 years of related experience
• Experience using Windchill