Regulatory Affairs Specialist - Shockwave Medical

Johnson & Johnson; Santa Clara (CA); Remote; USD 74,000 - 120,000; Full time

Job summary

Join a leading healthcare innovator as a Regulatory Affairs Specialist – Shockwave Medical, responsible for ensuring compliance and facilitating international submissions. This fully remote position seeks a candidate with a background in medical device regulations and strong analytical skills.

Qualifications

• At least 2 years of related experience or an advanced degree.
• Knowledge of domestic and international regulatory guidelines.
• Experience with medical device filings.

Responsibilities

• Assist with compiling, preparing, reviewing, and submitting regulatory submissions internationally.
• Support regulatory compliance and documentation for multiple countries.
• Collaborate with cross-functional teams to interpret standards and regulations.

Skills

Analytical skills

Problem-solving skills

Communication skills

Education

Bachelor's degree

Tools

MS Office

Adobe

Job description

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 – Shockwave Medical to join our team located in Santa Clara, CA. The position is FULLY REMOTE and can sit anywhere in the 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. We’re 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 treating atherosclerotic cardiovascular disease using sonic pressure waves for calcified plaque.

Position Overview

The Regulatory Affairs Specialist works closely with internal departments to meet regulatory requirements, supporting submissions and maintaining product files.

Essential Job Functions

• Assist with compiling, preparing, reviewing, and submitting regulatory submissions internationally.
• Coordinate with authorized representatives and local entities for product registration.
• Support regulatory compliance and documentation for multiple countries.
• Maintain licenses, registrations, and renewal documentation.
• Collaborate with cross-functional teams to interpret standards and regulations.
• Communicate effectively with stakeholders and interpret regulatory requirements.
• Evaluate import/export requirements.
• Write and edit technical documents, manage multiple tasks accurately.
• Support data development for regulatory submissions.
• Other duties as assigned.

Requirements

• Bachelor's degree with at least 2 years of related experience or an advanced degree.
• Ability to work collaboratively in a fast-paced environment.
• Knowledge of domestic and international regulatory guidelines.
• Experience with medical device filings (e.g., 510(k), IDE, PMA, EU submissions).
• Good judgment within policies and regulations.
• Ability to work independently or as part of a team.
• Strong analytical and problem-solving skills.
• Excellent communication skills.
• Proficiency in MS Office and Adobe.
• Medical device software background preferred.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or other characteristics protected by law.

If you require accommodations during the interview process, please contact us at [e-mail].

Compensation and Benefits

The base pay range is $74,000 - $119,600 in the US, and $86,000 - $138,000 in the Bay Area. Employees are eligible for bonuses, benefits, and participation in various incentive programs. Additional information can be found at http://www.careers.jnj.com/employee-benefits.