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

Ability to work collaboratively in a fast-paced environment while managing multiple priorities concurrently and maintaining accuracy

Ability to complete short- and long-term projects of moderate complexity with some guidance

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers   or contact AskGS to be directed to your accommodation resource.

Required Skills:

Preferred Skills:

Accountability, Analytical Reasoning, Business Writing, Communication, Confidentiality, Data Reporting, Detail-Oriented, Document Management, Legal Support, Medicines and Device Development and Regulation, Organizing, Process Oriented, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Teamwork

The anticipated base pay range for this position is :

$57,500.00 - $92,575.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Company’s long-term incentive program.

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

Vacation –120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year

Holiday pay, including Floating Holidays –13 days per calendar year

Work, Personal and Family Time - up to 40 hours per calendar year

Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits