Regulatory Affairs Specialists

Johnson & Johnson is hiring for a Sr. Regulatory Affairs Specialist to be located in Santa Clara, CA or remote in the United States.

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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Shockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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.

The Senior 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) specifically the Reducer Product business. 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 Canada. 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 Canada. May require supporting international regulatory team with submissions to other geographies.

+ 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 CAN 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**

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 (EU, UK, Australia, Japan, China, 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.

+ Class III medical device and/or engineering background or experience is preferred.

+ Proficiency in MS Word, Excel, Adobe and Power Point.

The anticipated base pay range for this position is $103,000 to $165,600.

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)).

+ 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.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits

This job posting is anticipated to close on January, 8, 2025. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as assigned or negotiated to meet the ongoing needs of the organization.

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.