Regulatory Affairs Analyst (Indirect Markets)

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:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Lima, Peru

Job Description:

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

We are searching for the best talent for a Regulatory Affairs Analyst to be in Lima, Perú.

Purpose
To develop a skill set enabling improved contributions while working under close supervision.

This role involves planning, directing, coordinating, and controlling regulatory affairs activities related to new and modified products worldwide, ensuring compliance with corporate policies and government regulations.

The position interprets new and changing regulations to uphold adherence to regulatory and government standards.

Key Responsibilities


* Assist in implementing compliance with regulations to ensure that developed, manufactured, or distributed products meet regulatory agency requirements.


* Conduct functional analysis and interpretation of scientific data to assess risk and create regulatory strategies, expediting new product introductions to the market.


* Contribute to cross-functional project teams in developing compliant policies and operational plans for timely commercialization of new and modified products in key markets.


* Facilitate distributor efforts to register and maintain the product portfolio in indirect market countries, ensuring adherence to all legal and technical documentation requirements.


* Lead all aspects of the entire lifecycle of registrations, including new applications, changes, and renewals.


* Provide support for Ministry of Health (MoH) notifications and ensure timely updates of internal platforms.


* Collaborate closely with the commercial team to execute global plans and assist in tenders, blockage, and eligibility processes.


* Carry out detailed regulatory submissions required for new and existing product approvals and registrations.


* Coordinate regulatory affairs interpretation and feedback in support of federal, state, and/or international regulations by preparing documentation and reports for internal and external audits.


* Understand and apply Johnson & Johnson’s Credo and Lead...