Remote Regulatory Affairs Supervisor – FDA Submissions & QA

Partner Company; United States; Remote; USD 80,000 - 117,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) plan

Paid parental leave

Fully remote work

Job summary

Partner Company is a pharmaceutical and medical device organization seeking a QA/regulatory affairs leader to supervise labeling and listing activities in a fully remote role within the United States.

You will oversee FDA submissions, quality investigations, and health hazard evaluations, while maintaining regulatory databases and ensuring CARES Act and UDI compliance. Strong leadership and cross-functional collaboration skills are essential.

Qualifications

• 4-8 years of experience in pharmaceutical/medical device QA or regulatory affairs.
• Strong knowledge of FDA regulations, labeling standards, and quality system procedures.
• Proven leadership and communication skills to manage cross-functional collaborations.

Responsibilities

• Supervise daily activities of labeling and listing specialists with coaching and guidance.
• Oversee FDA submissions, quality investigations, and health hazard evaluations.
• Maintain regulatory databases and ensure CARES Act and UDI compliance.

Skills

FDA regulations

Labeling standards

Quality system procedures

Leadership

Cross-functional collaboration

Job description

Partner Company is a pharmaceutical and medical device organization seeking a QA/regulatory affairs leader to supervise labeling and listing activities in a fully remote role within the United States.

You will oversee FDA submissions, quality investigations, and health hazard evaluations, while maintaining regulatory databases and ensuring CARES Act and UDI compliance. Strong leadership and cross-functional collaboration skills are essential.