Regulatory Affairs Innovator for IVD Devices

Regulatory Jobs; Sparks Corner (MD); On-site; USD 96,000 - 153,000; Full time

Job summary

BD in Sparks, MD is seeking a Regulatory Affairs Specialist (Innovation) to provide regulatory guidance and develop strategies for new product development, including FDA submissions for in vitro diagnostics, automated lab systems, and related software.

You will collaborate with R&D, Quality, Medical Affairs, Program Management and Marketing to guide products through regulatory development and approval, ensuring compliance with ISO 13485 and evolving regulations.

Qualifications

• Bachelor's degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, Pharmacy, or related field.
• 2–5 years of directly related regulatory experience in the in vitro diagnostic device and/or medical device area(s) (IVDs, medical devices, laboratory systems, or related regulatory healthcare technologies)

Responsibilities

• Serves as Regulatory Affairs SME on various NPD teams
• Works cross-functionally with R&D, Medical Affairs, Quality, Marketing, Program Management and other key organizational functions
• Recognizes and addresses potential regulatory risks with project plans
• Responsible for organizing and leading various FDA & EU IVDR submissions
• Serves as contact to FDA and Notified Body review teams during submission reviews/communication
• Recognizes and proposes continuous process improvements.

Skills

Regulatory expertise

FDA submissions

Cross-functional collaboration

Regulatory strategy

Microsoft Office

Education

Bachelor's degree in Regulatory Affairs or related field

Tools

Microsoft Office

Job description

BD in Sparks, MD is seeking a Regulatory Affairs Specialist (Innovation) to provide regulatory guidance and develop strategies for new product development, including FDA submissions for in vitro diagnostics, automated lab systems, and related software.

You will collaborate with R&D, Quality, Medical Affairs, Program Management and Marketing to guide products through regulatory development and approval, ensuring compliance with ISO 13485 and evolving regulations.