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Associate Director, Regulatory Affairs Lifecycle Innovation (RALI) CSS Franchise Lead
Requisition ID: 6503180103
Johnson & Johnson’s Cardiovascular& Specialty Solutions (CSS) Group within Medical Devices is recruiting for an Associate Director, Regulatory Affairs Lifecycle Innovation (RALI) CSS Franchise Lead to be located in Irvine, CA.
The Global Surgery and Global Orthopedic Regulatory Affairs Centers of Excellence have recently integrated to support all operating companies under Johnson & Johnson’s Medical Devices Division.
The CSS Group consists of six diverse businesses including Advanced Sterilization Products (ASP), Acclarent, Biosense Webster (BWI), Mentor, Neurovascular and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology, Surgical and Non-Surgical Aesthetics, Neurovascular and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
You, the Associate Director, RALI CSS Franchise Lead will be responsible for leading a team to execute the strategy for obtaining product registrations and supporting the lifecycle management of a defined global portfolio in designated International Wave countries. You will drive excellence in product registration innovation and lifecycle management processes. This position is also responsible for leading the CSS Regulatory Staff and providing direction in the implementation of global regulatory strategies and processes to assure timely commercialization of products in key markets in compliance with current and appropriate worldwide regulatory expectations.
- Direct and coordinate activities concerned with the submission and approval products to government regulatory agencies.
- Oversee timely regulatory clearances and approvals for product launches in all target markets.
- Coordinate with other Regional RALI leaders to develop and harmonize efficient processes for creating technical documentation required to register new products in markets and enable accelerated product approvals
- Develop and align project priorities across multiple business units through collaboration with internal RA partners and other functional business partners
- In partnership with the RALI Regional Portfolio Leaders, will develop plans and coordinate regulatory submissions to support product registrations and maintenance
- Provide guidance to project team members regarding regulatory issues.
- Oversee the prioritization, preparation and maintenance of regulatory submissions and files.
- Establish accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Ensure adherence to standard operating procedures and protocol for the rapid and timely approval of new products and regulatory support of marketed products.
- Consult with management personnel to establish and prepare appropriate regulatory filings for product approvals.
- Tactical and strategic regulatory and business knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products.
- Leverage scientific and technical understanding of medical devices and/or biologics to serve as an expert resource and strategic partner for development and planning throughout the product lifecycle in applicable markets.
- Build, sustain, and reward a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
- Advise and challenge others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo.
- Cultivate strong internal partnerships and collaborations both within MD RA and across business functions
- Drive innovative approaches and challenge the status quo to enable continuation of supply of MD products
- Acquire and develop a diverse team of talented regulatory professionals and transparently communicating in a constructive manner
- Mobilize and inspire an accountable team to deliver results for on-time clearances with a global and enterprise-wide mind-set and balance with strategic and short-term goals
- A Bachelor’s Degree and a minimum of 8 years relevant / regulated industry experience is required.
- A degree within a technical related discipline and/ or a M.S., M.E., PhD or MD is preferred.
- Previous experience with medical devices is strongly preferred.
- Demonstrated track record of developing and executing global regulatory strategies that align with business deliverables is required.
- Excellent written, verbal and presentation skills are required.
- Ability to partner and influence key stakeholders within MD RA and cross function business partners is required.
- Supervisory experience is required.
- Managing a diverse globally-dispersed team is preferred.
- This position will be located in Irvine, CA and may require up to 20% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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