Senior Regulatory Affairs Specialist

Lumicity; Pennsylvania; On-site; USD 120,000 - 170,000; Full time

Job summary

Lumicity is seeking an experienced Regulatory Affairs professional to support regulatory initiatives and help advance medical device products through development and commercialization.

The ideal candidate will bring strong medical device regulatory experience, the ability to work independently, and a collaborative approach to working with technical and quality teams.

Qualifications

• Requires a Bachelor’s degree in a scientific, engineering, or related discipline.
• 5+ years of Regulatory Affairs experience in medical devices.
• Hands-on experience with FDA regulatory submissions.
• Strong understanding of medical device regulations and Design Controls.

Responsibilities

• Support regulatory activities throughout the product development lifecycle.
• Develop and execute regulatory plans for medical device products.
• Prepare regulatory documentation and support product submissions.
• Provide regulatory guidance to cross-functional teams.
• Support U.S. and international market activities.
• Collaborate with internal teams to ensure regulatory requirements are met.
• Maintain regulatory documentation and support ongoing product compliance.

Skills

Regulatory expertise

FDA submissions

Cross-functional collaboration

Project management

Strong communication

Education

Bachelor's degree in science/engineering

Job description

Our client is an innovative medical device company looking to add an experienced Regulatory Affairs professional to their growing team. This individual will play an important role in supporting regulatory initiatives and helping advance medical device products through development and commercialization.

The ideal candidate will bring strong medical device regulatory experience, the ability to work independently, and a collaborative approach to working with technical and quality teams.

Core Responsibilities

• Support regulatory activities throughout the product development lifecycle
• Develop and execute regulatory plans for medical device products
• Prepare regulatory documentation and support product submissions
• Provide regulatory guidance to cross-functional teams
• Support U.S. and international market activities
• Collaborate with internal teams to ensure regulatory requirements are met
• Maintain regulatory documentation and support ongoing product compliance

Required Skills & Experience

• Bachelor's degree in a scientific, engineering, or related discipline
• 5+ years of Regulatory Affairs experience within medical devices
• Hands-on experience with FDA regulatory submissions
• Strong understanding of medical device regulations and Design Controls
• International regulatory experience (preferred)
• Experience working cross-functionally across product development
• Strong communication, organization, and project management skills