Senior Regulatory Affairs Program Lead - Johnson & Johnson MedTech

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 Product Submissions and Registration

Job Category:
Professional

All Job Posting Locations:
Galway, Ireland

Job Description:

We are searching for the best talent as Senior Regulatory Affairs Program Lead to be in Galway, Ireland.

Purpose of the role:

The Senior Regulatory Affairs Program Lead provides independent regulatory guidance to product development teams on International pre-marketing applications, and any related submissions to support optimal timelines for new/modified product launches and ongoing regulatory compliance.

What you will be doing?


* Helps define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.


* Leverages a deep scientific and technical understanding of regulated products under scope of responsibility to provide strategic guidance and support for product development and life-cycle management of products (e.g.

represents Regulatory in the complaint handling and field action process).


* Clearly defines and prioritises decision criteria, considers the benefits and risks of each solution before making decisions.

Considers all of the available facts when situations are ambiguous in order to make the best possible decision.


* Develops labelling specifications and approves proposed labelling and packaging, after evaluating conformance to regulations is required.


* Guides conformance with applicable regulations in product development, support of claims, content labelling, and promotional materials.

The role assists in the development of best practices for Regulatory Affairs processes


* Ensures compliance with regulatory agency regulations and interpretations.


* Prepares responses to regulatory agencies' questions and other correspondence.


* Provides regulatory advice to project teams.


* Guides conformance with applicable regulations in product development, support of claims and label content.


* Defines data and information needed for regulatory approvals.

Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.


* Assist in the development of product reimbursement strategies.

Lead applications for product reimbursements in line with company strategies.


* Provides Regulatory Affairs support during internal and external audits.


* Represents ...