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

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Johnson & Johnson is hiring for a Sr Regulatory Affairs Specialist – Shockwave to join our team located in Santa Clara, CA or Remote.

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 Sr. 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 Sr. Regulatory Affairs Specialist combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements with a focus on the United States and the EU. Under direction of responsible Regulatory Affairs Management, acts as a decision-maker on regulatory issues, assures that registration/renewal deadlines are met, and supports new product development.

Essential Job Functions

• Collaboratively interface with a variety of levels on significant matters, often requiring the coordination of activity across organizational units.
• Outline submission and approval requirements in assigned geographies.
• In consultation with Regulatory Affairs Management, develop sound regulatory strategies in alignment with business priorities and update strategy based upon regulatory changes.
• Provide regulatory input and technical guidance 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, 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 submit high-quality regulatory submissions to authorities on time in US and EU. Support international regulatory team with submissions to other geographies (e.g., Canada, Australia, Japan, etc.).
• In consultation with responsible Regulatory Affairs Management, interact and negotiate directly with regulatory authorities during the development and review process to ensure submission approvals.
• Communicate application progress to internal stakeholders.

• Evaluate and maintain current regulatory policies, processes, procedures.

• Effectively communicate, prepare, and negotiate both internally with cross-functional teams and externally with various regulatory agencies.
• Evaluate proposed design, clinical and manufacturing changes for regulatory impact and approve changes in compliance with Regulatory requirements.
• Prepare and maintain annual licenses, registrations/listings for assigned geographies in a timely manner.
• Support product safety evaluation and reporting (e.g., MDR/Vigilance) as required by country regulation.
• Provide regulatory input for product recalls and recall communications.
• Support quality system and technical file/design dossier audits.
• Maintain regulatory files and tracking databases as required
• Evaluate import/export requirements.
• Identify emerging issues.
• Provide other US and EU 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.

Requirements

• Minimum 5 years of regulatory affairs experience in the medical device industry with a Bachelor's degree; or 3 years and a Master’s degree; or a PhD without experience; or equivalent work 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.
• Must be able to travel as needed, approximately 2-3 times a year.
• 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. Experience with international filings is a plus (TGA, Health Canada, Shonin, CFDA, etc.).
• Ability to outline sound regulatory strategy in alignment with regulations and business priorities.
• Clear and effective verbal and written communication skills with diverse audiences and personnel.
• Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues.
• Must be highly organized with the ability to manage multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
• 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, Adobe and Power Point.

Additional Information:

The anticipated salary range for this position is

Bay Area $103, 000-$165, 600

Outside Bay Area $89, 000-$143, 750

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:

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