Regulatory Affairs Specialist, Ops - Johnson & Johnson MedTech, Circulatory Restoration

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, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Business Enablement/Support

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Regulatory Affairs Specialist, Ops to join our team located in Santa Clara, CA.

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, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Cardiovascular Solutions from Johnson & Johnson

Across Johnson & Johnson, we are tackling the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, we are addressing conditions with significant unmet needs such as heart failure, coronary and peripheral artery disease, stroke, and atrial fibrillation. We are the global leaders in heart recovery, circulatory restoration and the treatment of heart rhythm disorders, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. For more information on circulatory restoration, visit our website.

Position Overview

The Regulatory Affairs Specialist is an individual contributor who will help secure and retain global regulatory approvals for medical devices by creating, archiving, and maintaining specific categories of regulatory documentation and data. The function of the Regulatory Affairs Operations Specialist is to provide submission publishing/verification support and contribute to other Regulatory Infrastructure/Operations functions and projects.

Essential Job Functions

• Publish worldwide regulatory submissions in compliance with geography-specific regulatory requirements
• Track original and renewed annual licenses and registrations/listings, and collect/organize/disseminate, when required, registration renewal documentation
• Archive submissions, correspondence, and other regulatory documentation in a designated document repository according to a standardized format and process
• Author and route document changes via electronic document control system
• Provide other country specific regulatory support
• Procure document notarizations, authentications, legalizations, and certifications
• Contribute to continuous improvement of departmental processes and procedures
• Ensure personal compliance with applicable company policies and procedures
• Provide audit backroom support
• Other duties as needed

Requirements

• Bachelor's degree or equivalent experience; Bachelor's degree in science, math, engineering, or medical fields is preferred
• Minimum 2 years of experience in a regulatory position in a regulated healthcare industry or equivalent
• Highly proficient with MS Word, SharePoint (or equivalent), Excel, Adobe and PowerPoint; proficient with Word Macros and Styles
• Strong digital aptitude, including proficiency with digital systems and databases and the ability to efficiently learn and navigate new platforms and applications
• Flexible with changing priorities, ability to manage multiple tasks, prioritize and schedule work to meet business needs and timelines
• Organized, detail oriented, with good planning and time management skills
• Exercise sound and ethical judgment within policy and regulations
• Ability to think analytically with good problem-solving skills
• Clear and effective verbal and written communication skills with various levels of the organization
• Notary Public Commission, or willingness to obtain, is an asset
• Applies Johnson & Johnson’s Credo and Leadership imperatives in day-to-day interactions with internal and external colleagues

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