Senior Manager, Regulatory Affairs In Vitro Diagnostics and Companion Diagnostics (Remote) - AbbVie

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 atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.

The Senior Manager, RA In Vitro Diagnostics and Companion Diagnostics, works with internal and external partners to deliver products to patients. Supports regulatory objectives for the companys 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 provide 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 industrydevice regulatory product strategies and identifies data and information requirements.Seeks expert advice and technical support as required for strategies and submissions. Make decisions and provide guidance for supporting 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.
• Manage products and change control in compliance with regulations and company policies and procedures. Analyzes and approves change management requests.
• Develop device strategies for meetings with regulatory agencies and manage 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.

This a remote opportunity that can be based anywhere within the United States.

Qualifications:

• Required Education: Bachelors 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. Demonstrated success in directly securing regulatory clearance/approvals for In vitro diagnostic products required.
• 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. 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

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies 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.

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