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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Regulatory Affairs Specialist (Remote) – Shockwave Medical to join our team located in Santa Clara, CA and Remote US.

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/.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

Position Overview
The Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements. Under the direction of the Regulatory Affairs Team, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department, including submission support and maintenance of existing product files, and ensures that deadlines are met.

Essential Job Functions

• Assist with compiling, preparing, reviewing and submitting regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)
• Assist with the preparation of OUS product registration(s) documents by working with Authorized Representatives in EU, distributors, and/or Local Responsible Person (LRP)
• Provide other country specific regulatory support
• Maintain Regulatory shipping authorization documentation for assigned geographies
• Assist with review of R&D, quality, preclinical and clinical documentation for submission filing
• Prepare and maintain annual licenses, registrations/listings, and registration renewal documentation
• Work with Regulatory management, product development, quality and operations functions to assist with interpretation and compliance of applicable standards (e.g., ISO and IEC standards, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)
• Effectively communicates, prepares, and negotiates with internal stakeholders. Properly interprets and applies regulatory requirements.
• Evaluate import/export requirements
• Ensure personal compliance with applicable company policies and procedures
• Write and edit technical documents
• Ability to perform multiple tasks concurrently with accuracy
• Knowledge of business functions and cross group dependencies/relationships
• Support functional groups in the development of relevant data to complete a regulatory submission
• Other duties as assigned

Requirements

• Bachelor's degree and a minimum of 2 years of related experience; or an advanced degree 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 support such as 510(k), IDE, PMA, EU Technical Files, Design Dossiers, and/or international filings (TGA, Health Canada, Shonin, CFDA, etc.).
• Exercise good and ethical judgment within policy and regulations
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• Think analytically with good problem solving skills
• Clear and effective verbal and written communication skills with diverse audiences and personnel
• Proficiency in MS Word, Excel, Adobe and Power Point
• Some medical device software engineering background or experience is preferred

Additional Information:

The anticipated salary range for this position is

Outside of Bay: $74,000-$119,600

Bay Area: $86,000-$138,000

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be 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.
• Employees are eligible for the following time off benefits:
  • Vacation – up to 120 hours per calendar year
  • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
  • Holiday pay, including Floating Holidays – up to 13 days per calendar year
  • Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States.

· 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 and 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 email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

"Outside of Bay $74,000-$119,600 BA $86,000-$138,000"

Additional Description for Pay Transparency:

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/performance year. Bonuses are awarded at the Company’s discretion on an individual basis.

Push the boundaries of science to transform health—and your career.

Join us and advance life-changing treatments for people who need them most. At Johnson & Johnson, our focus is on improving global health equity and developing MedTech and pharmaceutical innovations that impact the future of health. Using AI and robotics to transform surgery or helping data scientists and clinicians formulate new ways to diagnose and treat disease, this work may sound like sci-fi, but it’s all science, all real, and could be your career. Whatever your background, skills, or career goals, there’s a place for you to help solve some of the world’s most pressing health challenges with us.

Accelerate your career while changing the world.

Each of our broadly-based family of companies offers an inclusive and empowering culture and employee benefits (like paid time off to volunteer, transgender-inclusive and same-sex partner health insurance coverage, and more) designed to help you live your best life, however you define it. And our best-in-class learning and development approaches, mentorship, and access to innovators across the world will help you grow your skills and reach your career goals. Because when you're at your best, nothing stands between you and your next breakthrough.