Regulatory Affairs Specialist II

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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.

Job Function:
Regulatory Affairs Group

Job Sub Function:
Regulatory Affairs

Job Category:
Professional

All Job Posting Locations:
Irvine, California, United States of America

Job Description:

Johnson & Johnson is recruiting for a Regulatory Affairs Specialist II, MedTech Neurovascular.

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 Summary

The Regulatory Affairs Specialist II position offers the opportunity to have a significant impact on patient access to innovative neurovascular products around the world!

The role will primarily support regulatory activities to obtain and maintain medical device approvals/clearances in the US and European markets.

This role will support preparation, submission, tracking, indexing, and archiving of official documents and files such as Technical Documents, amendments/supplements, annual reports, general correspondence, promotional materials, and other EU or US regulatory submissions.

The individual will work closely with other Global Regulatory Affairs partners and with functional partners in Research and Development (R&D), Medical Affairs, Quality, Supply Chain, Marketing, and other functions.

Key Responsibilities:

Under moderate supervision and in accordance with all applicable international, federal, state and local laws/regulations/requirements and Corporate Johnson & Johnson procedures and guidelines:


* Supports the preparation, compilation of regulatory submissions of technical and scientific medical device product information to US FDA, EU Notified Bodies, and other government regulatory agencies and assists in responding to regulatory authority queries and deficiency letters.


* This includes but is not...