Regional Regulatory Operations Specialist

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 jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

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 surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

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

Regional Regulatory Operations Specialist provides centralized regulatory operational support to ensure regulatory compliance, data accuracy, and product availability across supported markets. The role manages regulatory data and documentation, supports product lifecycle activities, facilitates tender and customer requests, and proactively identifies and resolves regulatory data issues impacting commercialization and supply continuity.

DUTIES & RESPONSIBILITIES

• Assess product eligibility for commercialization and distribution through ERP and regulatory system reviews.
• Initiate and coordinate restriction release requests when regulatory requirements are met.
• Monitor product status reports and identify discrepancies impacting order processing and product availability.
• Partner with Local Regulatory Affairs teams to resolve data inconsistencies between ERP and regulatory databases.
• Provide guidance on corrective actions required to support uninterrupted product supply.
• Maintain expertise in restriction management processes through ongoing collaboration with Business Units, Supply Chain, Quality, and Regulatory stakeholders.

• Support New Product Introductions (NPIs), product changes, discontinuations, and lifecycle maintenance activities.
• Maintain regulatory data and perform updates in MDRIM, ERP, Health Authority databases, and related systems.
• Execute impact assessments, regulatory actions, and license maintenance activities.
• Ensure regulatory data accuracy, completeness, and compliance.

• Maintain regulatory document repositories and certificate libraries.
• Provide regulatory certificates, licenses, declarations, and product documentation to Local Regulatory Affairs teams.
• Ensure documentation remains current, accurate, and accessible.

• Support tender submissions by providing regulatory documentation and compliance information.
• Respond to customer and market requests requiring regulatory documentation and expertise.
• Collaborate with commercial and local stakeholders to address regulatory inquiries and support business continuity.