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Companion Diagnostics
Key Responsibilities:
- Supervise daily activities of labeling and listing specialists, providing coaching and technical guidance.
- Oversee FDA submissions, quality investigations, and health hazard evaluations.
- Maintain regulatory databases and ensure compliance with CARES Act and UDI requirements.
Qualifications:
- 4-8 years of experience in pharmaceutical/medical device quality assurance or regulatory affairs.
- Strong knowledge of FDA regulations, labeling standards, and quality system procedures.
- Proven leadership and communication skills to manage cross-functional collaborations.
What We Offer:
- Competitive salary range of $79,700–$117,200 depending on location and experience.
- Comprehensive benefits including medical, dental, vision, 401(k), and paid parental leave.
- Fully remote work flexibility with a focus on work-life balance and inclusive culture.
Partner Company
The partner company is a pharmaceutical and medical device organization focused on ensuring regulatory compliance and product quality. The company fosters a collaborative and inclusive work environment, emphasizing continuous improvement and professional development.