Manager, Product Stewardship (Cardiovascular) - MedTech

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:

Cincinnati, Ohio, United States of America, Irvine, California, United States of America, Jacksonville, Florida, United States of America, Milpitas, California, United States of America, Palm Beach Gardens, Florida, United States of America, Raritan, New Jersey, United States of America, Raynham, Massachusetts, United States of America, Santa Clara, California, United States of America, Warsaw, Indiana, United States of America, West Chester, Pennsylvania, United States of America

Job Description:

About Cardiovascular

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Manager, Product Stewardship, to support the Global Cardiovascular Portfolio. The Manager, Product Stewardship, will lead the product stewardship program for Biosense Webster, Cerenovus, Shockwave, V-Wave, Laminar and Abiomed. The required location for this role is within a commutable distance from any J&J location in the United States. This role will work a Flex/Hybrid schedule with a minimum of 3 days per week in office. There is NO remote option.  An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.

Purpose: The Manager, Product Stewardship (PS) for Global Cardiovascular will lead the product stewardship program for J&J MedTech businesses that collectively make up the Global Cardiovascular franchises. The Manager is responsible for ensuring that these businesses are compliant with existing environmental product and packaging compliance and other stakeholder requirements. The Manager is responsible for communicating and escalating current and emerging product stewardship regulations, issues and risks and opportunities to Global Cardiovascular senior leadership to ensure global compliance for commercialized products and new product development.

You will be responsible for:

• The Manager collaborates closely with leaders in R&D, Supply Chain, Life Cycle Management, Project Management, Quality, Regulatory Affairs, Finance, Procurement, Packaging, Marketing, and other business groups across the Global Cardiovascular businesses to help manage business risks and institutionalize product stewardship programs in these businesses.
• The Manager will become a trusted business partner who will collaborate, inform, and guide business decisions to influence business strategy.
• The Manager will liaise with new product development (NPD) teams to ensure that all environmental product and packaging compliance and applicable regulated environmental sustainability requirements are considered during new product design and launch.
• The Manager will influence materials and suppliers’ selection to ensure that product stewardship and regulated sustainable product and packaging design considerations are included in new product development.
• The Manager supports and helps manage business/EtQ-generated CAPAs, providing guidance and leadership as needed to help the businesses close related CAPAs on-time, as well as provides CAPA status updates to relevant business leaders.
• The Manager supports Enterprise Regulatory Tracking and Governance by ensuring compliance with all global product stewardship requirements for Global Cardiovascular – including the J&J Enterprise Product Stewardship standard.
• The role is responsible for conducting product stewardship self-assessments, generating, and ensuring on-time closure of related CAPAs, and stewarding the completion of standard and regulation gap assessments through the internal Quality Systems process.
• Developing, maintaining, and ensuring the execution of internal PS and Business-facing Procedures.
• The Manager is responsible to partner with Product Stewardship Subject Matter Experts (SMEs) and the MedTech Product Stewardship Emerging Regulations (PSER) Specialist/team to ensure completion of impact assessments and updating of BU-specific Heat Maps for relevant emerging issues; ensuring that mitigation plans are in place and appropriate escalations have been made to relevant business partners that ensures readiness for emerging regulatory and other risks.
• The Manager will also partner with, and support as needed the MedTech PS Regional Execution Leads in EMEA and AP to facilitate the execution of regional PS action plans and communications and help inform advocacy and policy development efforts.
• Additional responsibilities include but are not limited to:
  • Conduct training of various disciplines / functions to build awareness of product stewardship regulations, emerging issues, and company policies.
  • Coordinate responses to customer Environmentally Preferred Purchasing (EPP) questions and responses to Request for Proposals (RFP) queries; Develop and Maintain documentation and management systems to ensure global product stewardship regulations are appropriately managed.
  • The Manager will also support Enterprise Sustainability (as requested) for these businesses.

Qualifications / Requirements:

• Minimum of a Bachelor’s degree or equivalent level of degree is required; Advanced degree strongly preferred. Preferred fields of study include chemistry, engineering, or related sciences.
• Minimum of 8-10+ years of relevant work experience.
• Relevant experience in medical devices required.
• Comfortable operating in a fast-paced dynamic environment with minimal supervision required.
• Familiarity and knowledge of global product stewardship regulations (REACH, RoHS, WEEE, EU Packaging & Packaging Waste Directive (PPWR), EU Batteries, CA Proposition 65, TSCA, etc.) strongly preferred.
• Experience in deploying regulatory compliance management systems and programs required.
• Ability to perform product stewardship risk assessments strongly preferred.
• Strong influencing skills and ability to engage senior business leaders is required.
• Ability to make a good business case and drive change is required.
• Strong collaboration skills and ability to effectively engage and convene diverse groups required.
• Strong attention to detail required.
• Strong English communication (both written and verbal) is required.
• Familiarity and knowledge of chemistry is preferred.
• Familiarity and knowledge of product stewardship technology tools is highly desired.
• Familiarity and knowledge of Global Cardiovascular platforms and J&J MedTech is preferred.
• Experience in leading multiple businesses units, functions and/or projects is preferred.
• Ability to travel up to 25% travel is 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 & 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.

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Fact-Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Risk Compliance, Strategic Thinking, Technical Credibility

 

 

The anticipated base pay range for this position is :

$117,000.00 - $201,250.00

 

 

For Bay Area:

$134,000.00 - $231,150.00

 

 

Additional Description for Pay Transparency:

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)).

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 Colorado –48 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

Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave – 80 hours in a 52-week rolling period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year

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