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

Johnson & Johnson•Santa Clara, CA

About The Position

Johnson & Johnson is hiring a Regulatory Affairs Specialist, Ops to join its team in Santa Clara, California. This individual-contributor role supports the global regulatory approval and maintenance of medical devices by creating, archiving, and maintaining regulatory documentation and data. The specialist provides regulatory submission publishing and verification support and contributes to regulatory infrastructure and operations functions and projects. The role includes publishing worldwide submissions in accordance with geography-specific requirements; tracking original and renewed licenses, registrations, and listings; and collecting, organizing, and distributing renewal documentation as needed. The specialist also maintains regulatory records in a designated repository, routes document changes through an electronic document control system, provides country-specific support, obtains document notarizations and related services, contributes to process improvement, and supports audits. The position may also include other duties as needed.

Requirements

Bachelor's degree or equivalent experience.
At least 2 years of experience in a regulatory position in a regulated healthcare industry or equivalent.
High proficiency with MS Word, SharePoint or equivalent, Excel, Adobe, and PowerPoint; proficiency with Word Macros and Styles.
Strong digital aptitude, including proficiency with digital systems and databases and the ability to learn and navigate new platforms and applications efficiently.
Flexibility with changing priorities and ability to manage multiple tasks, prioritize, and schedule work to meet business needs and timelines.
Organized, detail-oriented, and skilled in planning and time management.
Ability to exercise sound and ethical judgment within policies and regulations.
Analytical thinking and good problem-solving skills.
Clear and effective verbal and written communication skills with people at various organizational levels.
Ability to collaborate in a fast-paced environment while managing concurrent priorities and maintaining accuracy.
Ability to complete short- and long-term projects of moderate complexity with some guidance.
Apply Johnson & Johnson’s Credo and Leadership imperatives in day-to-day interactions with internal and external colleagues.

Nice To Haves

A bachelor's degree in science, math, engineering, or a medical field is preferred.
Notary Public Commission, or willingness to obtain one, is an asset.

Responsibilities

Publish worldwide regulatory submissions in compliance with geography-specific regulatory requirements.
Track original and renewed annual licenses, registrations, and listings; collect, organize, and disseminate renewal documentation when required.
Archive submissions, correspondence, and other regulatory documentation in a designated document repository using standardized formats and processes.
Author and route document changes through an electronic document control system.
Provide 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.
Perform other duties as needed.

Benefits

Consolidated retirement plan (pension) and 401(k) savings plan, subject to plan terms.
Eligibility to participate in the long-term incentive program.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with different amounts for certain states.
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 a birth, adoption, or foster care placement.
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.