Senior Director, Regulatory Affairs Global Strategy Implementation

Johnson & Johnson is currently seeking a Senior Director, Regulatory Affairs Global Strategy Implementation to join our team preferably located in Raritan, NJ, Cincinnati, OH or Santa Clara, CA. Additional J&J MedTech sites may be considered.

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.

The Senior Director, Regulatory Affairs Global Strategy Implementation partners with MedTech Surgery business unit regulatory and regional leaders to set strategic direction and priorities for product registration, launch, and changes in regulations. They will partner with MedTech Surgery business unit regulatory for the development and maintenance of strategies during pre-market, launch, and post market phases of product life cycle.

Major Duties & Responsibilities

• Responsible for establishing and maintaining relationships with Notified Bodies for the business unit.

• Manages execution and handles international requests for registrations, renewals, and discontinuations.

• Provides business unit RA presence and support in the region for locally specific processes e.g. Economic Operator, etc.

• Establishes standard operational procedures to achieve efficiency within the regulatory affairs organization, including collaborating with other functions to drive the development of regulatory processes and controls to ensure product compliance in a timely manner

• Monitors complex issues for market access of products in strategic markets, and, when necessary, develop and lead remediation activities.

• Builds strong and positive relationship with Regulatory leaders across MedTech and cross-sector as well as with cross-functional leaders in Supply chain and Commercial to be recognized as a trusted voice of the MedTech Surgery business.

• Participates, as needed, in the integration of acquisitions (due diligence initiatives and compliance assessments) and coordination of work related to divestitures

• Leads, builds, and develops a team of Regulatory professionals across multiple locations to ensure strong talent pipeline and budget adherence.

• Responsible for presenting business-related issues or opportunities to next management level e.g. dashboards, metrics

Qualifications

• Bachelor's degree with a minimum of 10 years of global, large, healthcare products industry related experience OR an Advanced Degree with a minimum 7 years of related experience is required

• The ability to represent the function during senior, cross-functional, or leadership interactions

• Proven track record of leadership success and the ability to develop people

• Proven track record of strategic planning and ability to partner and influence cross-functional department partners

• Strong results orientation and organization

• Ability to communicate effectively with a diverse clientele base

• Experience working collaboratively internally and with external partners

• Up to 20% travel internationally and domestically

The anticipated base pay range for this position is $193,000 to $333,500. California Bay Area - The anticipated base pay range for this position is $238,000 to $382,950.