Senior Manager, Regulatory Affairs - Device

Summary

Join AbbVie as a Senior Manager, Regulatory Affairs, Device and collaborate with internal and external partners to deliver innovative medical products to patients. You will be responsible for developing and implementing global regulatory strategies, preparing and managing regulatory submissions, and ensuring compliance with all relevant regulations. This role requires strong communication and collaboration skills, as well as a deep understanding of device regulations. The position offers remote flexibility or a hybrid schedule in AbbVie's Lake County, IL or Irvine, CA offices. A competitive compensation package is offered, including benefits such as paid time off, medical/dental/vision insurance, and 401(k). AbbVie also offers short-term and long-term incentive programs.

Requirements

• Knowledge of the ISO/CE process and global product registration process
• Experience with eCTD tools and EDMS applications
• Knowledge of global regulatory intelligence and policy to analyze external regulatory trends and internal compliance trends to drive proactive initiatives to ensure compliance for Device/Combination Products
• Understanding of device/combination product regulations [21 CFR Parts 3, 4, GCP, GLP, 210/211, 820 QSR (Design Control), European Medical Device Directives and Regulation (MDR/IVDR), ISO 13485, MDSAP, technical standards, CMDR SOR/98-282, TGA SR. 236:2002, ANVISA RDC No. 16, JPAL Ordinance 169, MFDS No. 219, ISO 14155, eCTD Module 3, ISO/IEC 62366, HE 74, device complaint handling/MDRs, human factors testing, device risk analysis (ISO 14971) and other global regulatory requirements for Allergan’s devices and combination products
• Bachelor’s Degree in Pharmacy, Chemistry, Biology or Pharmacology, Engineering or related subject
• 8 years pharmaceutical experience

Responsibilities

• Develops and manages content strategy for regulatory submissions, including INDs/CTAs and amendments, new marketing applications and supplements/variations
• Builds and maintains relationships within the Regulatory Affairs functional areas, Operations, and Research & Development (R&D) organizations
• Represents RA Device on teams such as product development, Global Regulatory Product Teams, and Operations brand teams to negotiate, influence, and provide strategic advice
• Prepares device regulatory product strategies
• Prepares and manages regulatory submissions, including new applications and amendments, renewals annual reports, supplements and variations, and responds to regulatory information
• Analyzes and interprets information that impacts regulatory decisions
• Seeks expert advice and technical support as required for strategies and submissions
• Reviews and revises regulatory submissions to effectively present data and strategy to regulatory agencies
• Responds to global regulatory information requests
• Develops strategies for device agency meetings, manages preparation for agency meetings, and manages content of pre-meeting submissions
• Manages products and change control with an understanding of regulations and company policies and procedures
• Analyzes and approves manufacturing change requests
• Represents RA Device on teams such as the product development, Global Regulatory Product Teams, and Operations brand teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions
• Stays abreast of regulatory procedures and changes in regulatory climate
• Analyzes legislation, regulation and guidance, provides analysis to the organization
• Develops, implements, and documents policies and procedures within the regulatory affairs department
• Participates in initiatives internal to RA Device

Preferred Qualifications

• Relevant advanced degree
• Certification
• 10 years pharmaceutical experience including 5-plus years in regulatory affairs or 5-plus years in Discovery, R&D, or Manufacturing
• Experience developing and implementing successful global regulatory strategies and working in a complex and matrix environment
• Strong oral and written communication skills

Benefits

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