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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 Principal Regulatory Affairs Specialist (Remote) – Shockwave Medical to join our team located in Santa Clara, CA or 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 Principal Regulatory Affairs Specialist is an individual contributor that works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Principal Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. Under direction of responsible Regulatory Affairs Management, works independently with minimal oversight, acts as a decision-maker on regulatory issues, assures that registration/renewal and other deadlines are met, and supports new product development, as assigned.

Essential Job Functions

• Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units

• Develop regulatory policies, processes and SOPs and may train key personnel on them

• Develop regulatory strategies and update strategy based upon regulatory changes

• Determine submission and approval requirements in assigned geographies and effectively communicate application progress to internal stakeholders

• Provide input and technical guidance on regulatory requirements to product development and operations teams

• Work with product development, quality and operations functions to identify applicable regulations/standards and assist with interpretation and compliance (e.g., ISO and IEC standards, REACH, ROHS, applicable sections of 21 CFR, regulatory agency guidance documents)

• Review and approve R&D, quality, preclinical and clinical documentation for submission filing

• In collaboration with cross-functional team members, compile, prepare, review and/or submit regulatory submissions to authorities in and outside the US, as assigned (e.g., EU, Canada, Australia, Japan, etc.)

• Interact and negotiate with regulatory authorities during the development and review process to ensure submission approvals

• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements

• Oversee the process for preparation and maintaining annual licenses, registrations/listings for assigned geographies

• Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation

• Provide regulatory input for product recalls and recall communications

• Review and approve advertising and promotional materials to ensure regulatory compliance

• Evaluate import/export requirements

• Identify emerging issues

• Provide other country specific regulatory support

• Effectively and accurately write and edit technical documents

• Plan and conduct meetings, create project plans and timelines, and manage projects

• Exercise good and ethical judgment within policy and regulations

• Perform multiple tasks concurrently with accuracy

• Provide guidance to functional groups in the development of relevant data to complete a regulatory submission

• Other duties as assigned.

Qualifications

• Typically requires a minimum of 10 years of related experience with a Bachelor’s degree; or 8 years and a Master’s degree; or a PhD with 4 years experience; or equivalent experience.Degree in science, math, engineering, medical or other technical fields and Class III medical device experience are preferred.

• Ability to work collaboratively in a fast-paced environment while managing multiple priorities.

• Detailed working knowledge of applicable domestic and international regulatory guidelines, policies and regulations.

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

• Ability to outline sound regulatory strategy in alignment with regulations and business priorities.

• Think analytically with good problem solving skills.

• Effectively negotiate internally and externally with regulatory agencies.

• Clear and effective verbal and written communication skills with diverse audiences and personnel.

• Knowledge of business functions and cross group dependencies/ relationships.

• Leadership of functional groups in the development of relevant data to complete a regulatory submission.

• Ability to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.

• Operate as a team and/or independently while demonstrating flexibility to changing requirements.

• Some medical device software engineering background or experience is preferred.

• Proficiency in MS Word, Excel and Power Point required.

Additional Information:

The anticipated salary range for this position is

Outside Bay Area $105,000-169,050

Bay Area $121,000-$194,350

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 Bay Area $105,000-169,050 Bay Area $121,000-$194,350

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.