Regulatory Affairs Specialist – IVD Innovation & Submissions

BD; Sparks Corner (MD); On-site; USD 95,900 - 153,400; Full time

Job summary

BD is seeking a Regulatory Affairs Specialist (Innovation) in Sparks Corner, Maryland. This role involves providing regulatory guidance and developing strategies for in vitro diagnostic products and preparing FDA submissions, such as Pre-IDEs and PMA.

The ideal candidate will have a Bachelor's degree and at least 5 years of experience in the regulatory field. Strong analytical and communication skills are essential, along with the ability to manage multiple projects effectively.

Qualifications

• Minimum 5 years of directly related regulatory experience in IVD or medical device areas.
• RAPS Certification preferred.
• Demonstrated experience in regulatory submissions.

Responsibilities

• Serve as Regulatory Affairs SME on NPD teams.
• Prepare FDA submissions and EU IVDR documentation.
• Identify and address regulatory risks.

Skills

Ability to analyze complex issues

Strong written and verbal communication skills

Ability to handle multiple tasks

Education

Bachelor’s degree in Regulatory Affairs or related field

Tools

Microsoft Office (Excel, Word, PowerPoint)

Job description

BD is seeking a Regulatory Affairs Specialist (Innovation) in Sparks Corner, Maryland. This role involves providing regulatory guidance and developing strategies for in vitro diagnostic products and preparing FDA submissions, such as Pre-IDEs and PMA.

The ideal candidate will have a Bachelor's degree and at least 5 years of experience in the regulatory field. Strong analytical and communication skills are essential, along with the ability to manage multiple projects effectively.