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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:

Irvine, California, United States of America

Job Description:

We are searching for the best talent for a **Manager, Regulatory Affairs (International Regulations)** to be located in Irvine, CA. _This role will work a Flex/Hybrid schedule with 3 days per week in office_ .

**Purpose** : The Manager, Regulatory Affairs, International Registrations develops and implements regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations and standards.

**You will be responsible for** :

+ Manages a team of individual contributors and/or supervisors, ensuring the effective identification and preparation of detailed international registration documentation that supports all stages of a medical device's lifecycle, from initial product registration through end-of-life, while meeting the documentation needs for international JNJ affiliates.

+ Directs resources to develop and implement methods for planning, directing, coordinating, and controlling the submission of international Regulatory documents to Regulatory agencies, including responses to global Health Authority inquiries.

+ Develops and sustains strategic relationships with RA affiliates, advising on the development and execution of local registration strategy.

+ Benchmarks Regulatory Affairs strategies, assessments, and policies to guide cross-functional teams on international RA issues in developing registration plans to ensure timely commercialization of new and modified products in international markets.

+ Ensures compliance by communicating the interpretation of new and changing government regulations to uphold regulatory/government standards.

+ Oversees the maintenance of Regulatory Affairs databases and communication tools, including the SharePoint site, Regulatory databases, request tracking systems, and electronic libraries.

+ Assists with the development of product policies by reviewing, and revising company SOPs as required.

+ Supervises interaction with internal and external stakeholders to manage the procurement of necessary documentation for international regulatory activities.

+ Develops tactical plans for global planning to ensure visibility, alignment, and optimal resource allocation.

+ Provides support for internal and external regulatory agency audits, when necessary.

+ Manages operational aspects of their team (e.g., workflow, performance, and compliance), and ensures achievement of team goals within established timelines and budgets.

+ Responsible for communicating business related issues or opportunities to next management level.

+ Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.

+ For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.

+ Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

+ Performs other duties assigned as needed.

**Qualifications / Requirements** :

+ Minimum of a Bachelor’s Degree **required** , Advanced Degree _strongly preferred_ .

+ At least 8+ years of relevant experience in the medical device industry with at least 6+ years in Regulatory Affairs of Medical Devices.

+ Minimum 2 years of supervisory experience.

+ Regulatory experience in the cardiovascular/cardiology field and/or with devices containing software _strongly preferred_ .

+ Experience in international regulatory requirements (APAC/LATAM/EMEAC) for medical devices _highly desired_ .

+ Proven ability to manage a diverse globally dispersed team is preferred.

+ Proven expertise in international regulatory requirements and ability to translate regulations into clear deliverables to support registrations and ensure lifecycle maintenance of all products.

+ Strong understanding of Medical Device regulations / standards and Quality principles.

+ Extensive hands-on experience in activities such as product approval applications, regulatory submission management and negotiation with regulatory bodies worldwide. Ability to manage multiple priorities effectively.

+ Strong interpersonal and organizational and problem-solving skills.

+ A strong results-orientation and sense of urgency.

+ Ability to partner and influence key stakeholders within MedTech RA and cross functional business partners.

+ Excellent written and verbal communications skills in English (required).

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 ([email protected]) or contact AskGS to be directed to your accommodation resource.

\#LI-Hybrid

The anticipated base pay range for this position is :

The base pay range for this position is $115,000 to $197,800.

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)). 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