The Senior Manager, RA Device/Combination Products works with internal and external partners to deliver products to patients. Supports regulatory objectives for the company’s development and marketed device/combination products including coordination, management of device and In Vitro Diagnostic (IVD) global submissions and CE technical files/design dossiers. Provide support to submission activities for a variety of IVD device regulatory approvals including CE mark, US PMAs, US IDEs, US 510(k), DE NOVO, post-approval reports, annual reports, export certificates, establishment registrations and device listings. Support the development of the device regulatory strategy and provides device input into the preparation and maintenance of chemistry, manufacturing, and controls (CMC) device sections of regulatory submissions, responses to Agency questions for worldwide registration and lifecycle management for the assigned medical device or device aspect of combination products. Support regulatory intelligence and policy activities in monitoring regulatory pathways, legislation updates, policies and initiatives that could impact initial product submissions, marketed products. Support AbbVie at Regulatory Authority/Notified Body project-specific meetings as well as industry meetings. Supports due diligence activities and Agency audits/inspections as needed. The employee must carry out his/her responsibilities in compliance with all relevant laws, regulations, and regulatory guidance as well as all AbbVie policies and procedures.

　　Responsibilities:

　　Develops and prepares pre-market regulatory experience in IVD industry. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required. device regulatory product strategies and identifies data and information requirements. Seeks expert advice and technical support as required for strategies and submissions. Makes decisions and provides guidance for support of medical devices and combination products.

　　Manages the preparation and management of regulatory applications for devices and combination products, including new investigational applications and amendments, device technical files for pre-market notification and approval, and post-approval change applications. Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies.

　　Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves change management requests.

　　Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions. Serves as the point of contact for the regulatory agency meetings.

　　Regularly informs regulatory management of important timely issues.

　　Develops and implements policies and procedures within the regulatory affairs department.

　　Analyzes legislation, regulation, and guidance and provides analysis to the organization.

　　Represents RA Device on product development teams and design control teams, Global Regulatory Product Teams, and Pipeline Commercialization Model teams for assigned projects; negotiates with and influences team members to maximize chances for first pass approval of regulatory submissions.

　　Represents RA Device on project initiatives with other groups to drive efficiencies across the company.

　　Qualifications:

　　Required Education: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject.

　　Preferred Education: Relevant advanced degree preferred.

　　Required Experience: 8+ years of industry experience with IVD, companion diagnostics, medical devices, or combination products. 5+ years in quality systems or cross-functional project management.

　　Experience working in a complex and matrix environment.

　　Strong communication skills, both oral and written.

　　Preferred Experience: 5+ years of pre-market regulatory experience in IVD industry. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required.10+ years biopharmaceutical experience in R&D, Quality, or Manufacturing supporting devices and drug/device combination products.

　　Experience developing and implementing successful global regulatory strategies.

　　Experience working with Health Authorities

　　AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.