Regulatory Affairs Specialist - Shockwave Medical

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

Job summary

A leading healthcare company is seeking a Regulatory Affairs Specialist for its Santa Clara location. This role, fully remote, involves working closely with internal teams to ensure compliance with regulatory requirements. The successful candidate will have a Bachelor's degree and a minimum of two years' relevant experience.

Benefits

Annual performance bonus

Medical, dental, and vision insurance

401(k) retirement plan

Flexible paid time off

Qualifications

• Minimum of 2 years of related experience.
• Working knowledge of international regulatory guidelines.
• Ability to manage multiple priorities in a fast-paced environment.

Responsibilities

• Assist with regulatory submissions to authorities.
• Maintain regulatory shipping authorization documentation.
• Prepare and maintain annual licenses and registration renewals.

Skills

Regulatory guidelines

Technical writing

Analytical thinking

Problem solving

Collaboration

Education

Bachelor's degree

Advanced degree preferred

Tools

MS Word

Excel

Adobe

Power Point

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 Medica l 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. 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

al Files, Design Dossiers, and/or international filings (TGA, Health Canada, Shonin, CFDA, etc.). Experience with pre- and post-market medical device submissions support such as 510(k), IDE, PMA, EU Technic

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

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 ([e-mail]) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :

US: $74,000 - $119,600 / Bay Area: $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. 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 of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

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