Sr. 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

Job Function:
Legal & Compliance

Job Sub Function:
Enterprise Compliance

Job Category:
People Leader

All Job Posting Locations:
IE007 Castletroy Limerick, US076 FL Jacksonville - 7500 Centurion Pkwy

Job Description:

Job position summary:​


* Responsible for directly managing the global internal audit and regulatory compliance functions for J&J Vision Care, including development of goals and assuring management oversight and governance.


* Assure internal audits and assessments are conducted for compliance with the applicable international regulatory requirements (e.g., FDA QSRs, FDA cGMP, ISO 13485, Japanese MHLW, Brazilian ANVISA, EU MDR) for the company's products, including medical devices, combination products, and pharmaceuticals.


* Provide support to the MedTech segment in the performance of audits or audit-related activity.


* Functional responsibilities include internal audits, 3rd party inspection readiness and management, and Quality System compliance training programs.


* Lead and participate on cross-functional and global teams representing key stakeholders in developing and managing policies, standards, and procedures.

This includes developing procedures and practices that can be deployed globally.


* Partner with J&J Vision sites and related organizational units to ensure that regulatory compliance procedures are compliant, effective, and efficient.

Use partner input to ensure that the overall enterprise objectives are achieved.


* Represent JJV RC and J&J Vision on JJRC teams and working groups.

Provide input into segment initiatives.

Interpret and integrate resulting segment policies and standards into J&J Vision global operations.


* Manage FDA and other governmental or ISO Notified Body inspections conducted at JJVC locations, including pre- and post-inspection support, as requested.

Serve as company representative during regulatory inspections.

Support activities may include actively and directly interacting with inspectors/auditors, obtaining required information, and assisting with corrective action and/or remediation plans, as necessary.


* Manage associated assessment and remediation activities as a result of internal and external assessments.

Align and deploy JJV Quality System procedures (worldwide) in accordance with segment and enterprise standards.


* Consult with management, manufacturing, R&D, and laboratory staff to help formulate and i...