VP, Global Regulatory Affairs Heart Recovery

Johnson & Johnson Innovative Medicine•Danvers, MA

10d•$218,000 - $401,350•Onsite

About The Position

Johnson & Johnson Med Tech is recruiting for a Vice President of Global Regulatory Affairs, Heart Recovery located in Danvers, Massachusetts! About MedTech Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech About Cardiovascular Are you passionate about improving and growing the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops 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. The VP of Global Regulatory Affairs will be responsible for directing all regulatory affairs activities for Heart Recovery to ensure the business unit, corporate and agency global product registration and compliance objectives are met. The position reports directly to the WW President of Heart Recovery with connectivity to the MedTech Regulatory organization. The role will be a member of both leadership teams. This role develops methodology for the business unit’s Regulatory Affairs strategies, assessments, and policies accounting for new and changing government regulations. This role leads resources internally and externally to ensure compliance with regulatory agency regulations and interpretations and advises management on trends in the global regulatory environment. As a leader, this role directs multiple teams led by Senior Directors, Directors, and/or occasionally other VPs and senior individual contributors. The VP, Regulatory Affairs will define functional strategies and risk management policies by considering corporate strategies and compliance regulations to drive innovation and ensure timely commercialization of new and modified products into key markets. This role requires a deep understanding of cardiovascular diseases, clinical trials, and regulatory agency requirements (FDA, EMA, PMDA).

Requirements

Bachelor’s degree in Life Sciences/Health Science or related field.
15+ years of Regulatory Affairs experience within cardiovascular disease, and minimum of 8 years leading high performing teams.
Class III device experience required.
Leadership & Influencing Skills Cross‑functional influence, stakeholder alignment, coaching and talent development, crisis leadership
Proven sustained record of successful interactions with FDA and other international regulatory bodies.
Regulatory Strategy & Policy Pathway selection, lifecycle planning, regulatory risk assessment, negotiation strategy for pre‑submissions.
Domain specific technical skills: Cardiovascular, Class III Device, digital/cyber
Proven scientific writing skills, including ability to evaluate, interpret and present complex data.
Submissions/Publishing & Regulatory Information Management Documentation assembly, eCTD publishing, submission filing, metadata/RIM hygiene, version control.
Post Market Regulatory & Compliance Signal detection/triage, PSUR/PBRER/PMCF design, variations, recalls/field actions, country reporting rules.
Regulatory Intelligence & Government Affairs Horizon scanning, guidance interpretation, competitor/regulatory landscape analysis
Legal & Labeling/Marketing compliance interface Label text, IFU, claims substantiation, promotional review for local markets.
Inspection & Audit readiness Mock inspections, CAPA management, evidence orchestration, inspection response writing
Project Management and Regulatory Operations Integrated submission calendars, RACI, milestone tracking, vendor management, budget control
Ability to travel up to 30%.

Nice To Haves

Advanced Degree (Masters. PhD, MD) preferred.

Responsibilities

Leads communications to develop regulatory compliant plans by collaborating with internal stakeholders including Research & Development (R&D), Marketing, Sales, Quality, Clinical Affairs, and other leaders to create strategies for driving the optimum portfolio of innovative products and pipeline needs.
Partners with leaders to monitor the regulatory environment and assess the impact of new and changing regulations on the company's portfolio of products to strengthen product development and regulatory strategies.
Leads the development of operational strategies for regulatory submissions in support of new product introductions to ensure timely approval for market release.
Controls all systems for quality and accuracy monitoring to ensure new and existing products meet government regulations.
Engages internal and external stakeholders to influence regulatory policies and drive convergence between future regulatory policy and company functional plans.
Interprets regulatory guidance and develops strategic regulatory advice for team members to bring about process and technical improvements within the organization.
Adapts business strategy into functional strategy with short- to medium-term impact on corporate function or business unit (e.g., 1 -5 years) and manages operational aspects of their teams (e.g., budget, performance, and compliance).
Creates a purpose driven culture in which decisions and actions are strategically informed by patients, customers, and employee needs by aligning Johnson & Johnson’s Credo and Leadership Imperatives with the strategies and goals of the team and enterprise.
Partner with J&J Regulatory resources for the development and maintenance of labeling and related documents for all organizational products throughout the product lifecycle and participates in negotiations with governmental regulatory agencies for labeling that will ensure clear communication of product attributes and potential risks to comply with organizational policies and external regulations.
Administers resources to identify and design improvement opportunities to reduce compliance risk and promote continuous improvement in the design and development of high-quality products

Benefits

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.
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year