J&J Family of Companies
Senior Regulatory Affairs Specialist - Shockwave Medical
J&J Family of Companies, Honolulu, Hawaii, United States, 96814
J&J Family of Companies - Senior Regulatory Affairs Specialist - Shockwave Medical
Johnson & Johnson is hiring for a Sr. Regulatory Affairs Specialist to be located in Santa Clara, CA or remote in the United States. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently meet assigned regulatory requirements for Shockwave Medical, Inc. (SWMI) specifically the Reducer Product business. Essential Job Functions
Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units. Outline submission and approval requirements in assigned geographies. Develop sound regulatory strategies in alignment with business priorities. Provide regulatory input and technical guidance to product development and operations teams. Work with product development, quality and operations functions to identify applicable regulations/standards. Review and approve R&D, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit high-quality regulatory submissions to authorities on time in US and Canada. Interact and negotiate directly with regulatory authorities during the development and review process. Evaluate and maintain current regulatory policies, processes, procedures. Prepare and maintain annual licenses, registrations/listings for assigned geographies. Support product safety evaluation and reporting as required by country regulation. Maintain regulatory files and tracking databases as required. Identify emerging issues and provide other US and CAN country-specific regulatory support. Effectively and accurately write and edit technical documents. Plan and conduct meetings, create project plans and timelines, and manage projects. Perform multiple tasks concurrently with accuracy. Qualifications
Requirements
Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience. Ability to work collaboratively in a fast-paced environment while managing multiple priorities. Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations. Experience with pre- and post-market medical device submissions. Clear and effective verbal and written communication skills. Must be highly organized with the ability to manage multiple projects/tasks simultaneously. Proficiency in MS Word, Excel, Adobe and Power Point. The anticipated base pay range for this position is $103,000 to $165,600. The Company maintains highly competitive, performance-based compensation programs. This job posting is anticipated to close on January 8, 2025. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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Johnson & Johnson is hiring for a Sr. Regulatory Affairs Specialist to be located in Santa Clara, CA or remote in the United States. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured. Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. The Senior Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently meet assigned regulatory requirements for Shockwave Medical, Inc. (SWMI) specifically the Reducer Product business. Essential Job Functions
Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units. Outline submission and approval requirements in assigned geographies. Develop sound regulatory strategies in alignment with business priorities. Provide regulatory input and technical guidance to product development and operations teams. Work with product development, quality and operations functions to identify applicable regulations/standards. Review and approve R&D, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit high-quality regulatory submissions to authorities on time in US and Canada. Interact and negotiate directly with regulatory authorities during the development and review process. Evaluate and maintain current regulatory policies, processes, procedures. Prepare and maintain annual licenses, registrations/listings for assigned geographies. Support product safety evaluation and reporting as required by country regulation. Maintain regulatory files and tracking databases as required. Identify emerging issues and provide other US and CAN country-specific regulatory support. Effectively and accurately write and edit technical documents. Plan and conduct meetings, create project plans and timelines, and manage projects. Perform multiple tasks concurrently with accuracy. Qualifications
Requirements
Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work experience. Ability to work collaboratively in a fast-paced environment while managing multiple priorities. Working knowledge of applicable domestic and international regulatory guidelines, policies and regulations. Experience with pre- and post-market medical device submissions. Clear and effective verbal and written communication skills. Must be highly organized with the ability to manage multiple projects/tasks simultaneously. Proficiency in MS Word, Excel, Adobe and Power Point. The anticipated base pay range for this position is $103,000 to $165,600. The Company maintains highly competitive, performance-based compensation programs. This job posting is anticipated to close on January 8, 2025. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
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