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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:

People Leader

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a **Manager, Regulatory Affairs – Shockwave Medica** l to join our team. The position is **FULLY REMOTE** and can sit anywhere in the US **.**

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 Manager works closely and partners with internal departments to efficiently and effectively meet assigned regulatory requirements for Shockwave Medical Inc. (SWMI). The Regulatory Affairs Manager combines knowledge of scientific, regulatory and business issues to ensure that products are developed, manufactured and distributed to meet regulatory requirements. With guidance from responsible Regulatory Affairs Management, functions independently as a decision-maker on regulatory issues, assures that submission/registration/renewal deadlines are met, and supports new product development. Effectively communicates, prepares, and negotiates both internally and externally with various regulatory agencies. The Regulatory Affairs Manager properly interprets and applies regulatory requirements and is recognized as a discipline expert and resource in Regulatory Affairs.

Essential Job Functions

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

+ Manage, mentor, and develop direct reports to meet individual and company goals and objectives

+ Develop and follow 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

+ Provide strategic 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 submit regulatory submissions to authorities in and outside the US (e.g., EU, Canada, Australia, Japan, etc.)

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

+ Communicate application progress to internal stakeholders

+ 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

+ Direct 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

+ In collaboration with Regulatory Management, develop, communicate, and build consensus for regulatory goals that are in alignment with the company

+ 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

Requirements

+ Minimum 10 years’ experience preferred in a regulated healthcare industry with 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

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

+ 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, etc.

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

+ Think analytically with excellent 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

+ Able to follow scientific arguments, identify regulatory scientific data needs and solve regulatory issues

+ Able to effectively lead direct reports while demonstrating flexibility to changing environments.

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

+ Proficient in MS Word, Excel and Power Point

_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 & 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 contact us via_ _https://www.jnj.com/contact-us/careers_ _or contact AskGS to be directed to your accommodation resource._

The anticipated base pay range for this position is :

US: $115,000 - $197,000 / Bay Area: $141,000 - $227,700

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. Subject to the terms of their respective plans, employees are 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. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits