Senior Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics
6 days ago
AbbVie is a leading biopharmaceutical company that aims to discover and deliver innovative medicines and solutions to address serious health issues. As a Senior Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics, you will play a crucial role in supporting the company's development and marketed device/combination products.
Key Responsibilities:
- Develop and implement regulatory strategies for In Vitro Diagnostic (IVD) and Companion Diagnostic products, ensuring compliance with regulatory requirements.
- Manage the preparation and submission of regulatory applications, including CE technical files/design dossiers, US PMAs, US IDEs, US 510(k), and DE NOVO.
- Collaborate with internal and external partners to deliver products to patients, ensuring timely and effective regulatory submissions.
- Provide support for regulatory intelligence and policy activities, monitoring regulatory pathways, legislation updates, policies, and initiatives that impact initial product submissions and marketed products.
- Represent AbbVie at Regulatory Authority/Notified Body project-specific meetings and industry meetings, ensuring effective communication and collaboration.
Qualifications:
- Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or a related subject.
- 8+ years of industry experience with IVD, companion diagnostics, medical devices, or combination products, with 5+ years in quality systems or cross-functional project management.
- Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products.
- Strong communication skills, both oral and written, with experience working in a complex and matrix environment.
About AbbVie:
AbbVie is an equal opportunity employer committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. We strive to create a work environment that is inclusive, respectful, and supportive of all employees.
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