Associate Director, Regulatory Affairs Devices and Combination Products

Summary

Join AbbVie as an Associate Director, Regulatory Affairs Devices and Combination Products and contribute to delivering innovative eye care products to patients. You will play a key role in managing global regulatory submissions, developing regulatory strategies, and ensuring compliance. Responsibilities include preparing pre-market submissions, managing regulatory applications, and analyzing legislation. This position requires strong leadership and communication skills, along with extensive experience in regulatory affairs and medical devices. The role offers opportunities for professional development and is based in Irvine, CA or remotely within the US. AbbVie provides a comprehensive benefits package, including paid time off, health insurance, and retirement plans.

Requirements

• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject
• 12+ years pharmaceutical or industry related experience
• 5+ years in quality systems and process improvement or regulatory affairs
• Proven 7+ years in a leadership role with strong management skills
• Experience working in a complex and matrix environment
• Strong communication skills, both oral and written

Responsibilities

• Develops and prepares pre-market regulatory submissions
• 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 device 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
• 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

Preferred Qualifications

• Relevant advanced degree preferred
• Certification a plus
• 5 years in regulatory affairs
• 10 years pharmaceutical experience (medical device/combination product)
• 5 years in Discovery, R&D, or Manufacturing
• Experience developing and implementing successful global regulatory strategies
• Experience working with Health Authority

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs