Regulatory Affairs Specialist, International RA

5 days ago

Yoqneam Illit, Northern District, Israel Johnson & Johnson Full time ₪60,000 - ₪120,000 per year

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

Job Function:

Regulatory Affairs Group

Job Sub Function:

Regulatory Affairs

Job Category:

Professional

All Job Posting Locations:

Yokneam, Israel

Job Description:

Under close supervision, identifies and prepares

detailed international registration documentation that

supports all stages of a medical device's lifecycle, from

initial product registration through end-of-life, ensuring

that all documentation needs for international JNJ

affiliates are met effectively.

 Applies methods for planning, directing, coordinating,

and controlling the submission of international

Regulatory documents to Regulatory agencies,

including but not limited to responses to global Health

Authority inquiries.

 Develops and sustains relationships with RA affiliates

as their primary point of contact, contributing to the

development and execution of local registration

strategy.

 Contributes on cross-functional project teams on

international RA issues in the development of

registration plans to ensure timely commercialization of

new and modified products into international markets.

 Applies functional analysis and interpretation of new and

changing government regulations to ensure compliance

with regulatory/government standards.

 Maintains Regulatory Affairs databases and

communications tools, including SharePoint site,

Regulatory databases, request tracking systems, and

electronic libraries.

 Writes, reviews and revises company SOPs as required.

 Coordinates with internal and external stakeholders to

obtain necessary documentation required for

international regulatory activities.

 Assists with global planning to help ensuring visibility,

alignment, and optimal resource allocation.

Communicates business related issues or opportunities

to next management level.

 Follows all Company guidelines related to Health,

Safety and Environmental practices as applicable.

 Ensures personal and Company compliance with all

Federal, State, local and Company regulations, policies,

and procedures

 Performs other duties assigned, as needed.

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