Associate Director, Regulatory Affairs Devices and Combination Products (Hybrid or Remote)

Associate Director, Regulatory Affairs Devices And Combination Products

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.

The Associate Director, Regulatory Affairs Devices And 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 global submissions, and CE technical files / design dossiers.

Provide support to submission activities for a variety of 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. Provide regulatory support, project management and leadership for the (Medical Device Regulation MDR) 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.

This position focuses on eye care devices and next generational eye care medicinal delivery products.

Responsibilities :

• Develops and prepares pre-market regulatory submissions.
• Manages the preparation and management of regulatory applications for devices and combination products.
• Manages products and change control in compliance with regulations and company policies and procedures.
• Develops device strategies for meetings with regulatory agencies and manages the content and preparation of information packages for pre-meeting submissions.
• Regularly informs regulatory management of important timely issues.
• Trains, develops, and mentors individuals.
• 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.

This opportunity can be based in AbbVie's Irvine, CA office or remotely within the US.

Qualifications :

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

Note : No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

US & Puerto Rico only - to learn more, visit https : / / www.abbvie.com / join-us / equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

https : / / www.abbvie.com / join-us / reasonable-accommodations.html

Travel : Yes, 10% of the Time

Salary : $137,500 - $261,000