Associate Director, Ra In Vitro Diagnostics And Companion Diagnostics (Remote)

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

The Associate Director Regulatory Affairs, In Vitro Diagnostics and Companion Diagnostics works with internal and external partners to develop and implement global regulatory strategies for In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Supports regulatory objectives for the management of IVD/CDx global submissions and CE technical files/design dossiers. Provide support for 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 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. Provide regulatory support, project management and leadership for the (Medical Device Regulations – MDR and IVDR) implementation globally. 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. May supervise others.

Responsibilities:

• Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required. Develops 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 IVD/CDx products.
• Assist with preparation of submissions, supplements, and correspondence with regulatory authorities, including Performance Evaluation Applications under IVDR, requests for Study Risk Determinations and Investigational Device Exemption (IDE) 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.
• Trains, develops, and mentors individuals; may include formal supervisory responsibilities.
• 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.

This individual can work remotely within the U.S.

Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day),Keyboard use (greater or equal to 50% of the workday)

• 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. 5+ years in quality systems or cross-functional project management. Proven 3+ years in a leadership role with strong management skills
• 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 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.