Manager Regulatory Compliance

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.

We are searching for the best talent for Manager Regulatory Compliance to be in Sao Jose dos Campos, Brazil.

You will be responsible for :


* Manager Regulatory Compliance is expected to provide key oversight and support for Regulatory Compliance and Outreach for the sites.

Establishes internal strategies, policies, procedures, processes, and programs to prevent violations of law, rule, or regulation and design and deliver a risk management framework that maintains appropriate levels of risk and protects the company


* Implement and execute internal audits program at the site (schedule, agenda, prepare and conduct audit, report writing, review of internal audits investigation responses).


* Responsible for training and qualifying auditors.


* Facilitate, support and host as needed the external GMP audits and inspections (Health Authority, Customer), including the coordination of inspection back room.


* Lead the Inspection Readiness process for announced and unannounced Health Authority and Notified body audits and lead compliance walk-throughs, audit preparation, coaching the SMEs.


* Support the development and review of external Health Authority and notified body observation responses (appropriate response, investigation, corrective actions, timing, execution)


* Provide compliance subject matter expertise to the manufacturing site, including identifying changes in regulations that impact procedures and current practices.


* Implement compliance initiatives and projects at the site, in alignment Johnson & Johnson Regulatory Compliance (JJRC) and with MedTech and Ethicon policies and procedures.


* Partners with stakehol...