Offer summary

Qualifications:

Bachelor's degree in a relevant field; advanced degree preferred., Strong knowledge of regulatory requirements for medical devices, particularly Class III devices., Excellent written and verbal communication skills, with the ability to influence stakeholders., Experience in regulatory affairs and compliance within the healthcare or MedTech industry..

Key responsibilities:

Manage the preparation and submission of regulatory documents for neurovascular devices.

Provide regulatory guidance to product development teams throughout the product lifecycle.

Interact with regulatory agencies to expedite approvals and resolve issues.

Supervise and ensure compliance of team members with health and safety regulations.

Job description

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:

Galway, Ireland

Job Description:

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

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

Role Purpose:

The Regulatory Affairs Manager is Responsible for managing and directing the preparation, submission, tracking, indexing and archiving of official documents and files such as amendments, annual reports, general correspondence, adverse event reports, promotional materials and standard regulatory submissions. They may be responsible for supervising or managing other professionals.

What you will be doing:

Develops world-wide regulatory strategies to ensure rapid and timely approval of Neurovascular devices and continued regulatory support of marketed devices and other products.
Provides guidance to project team members regarding regulatory and compliance issues by providing independent regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
Oversee the preparation and maintenance of regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, HDE/HDE Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of neurovascular products, including Class III devices.
Establishes accountability for the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new devices and regulatory support of marketed devices.
Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters.
Consults with management personnel to establish and prepare appropriate regulatory filings for product approvals.
Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
Responsible for presenting business related issues or opportunities to next management level
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed

What you will bring:

Excellent written, verbal communication and presentation skills
Tactical and strategic regulatory and business knowledge necessary to gain approval and ensure maintenance of legal marketing status of all products, including Class III devices (US and EU).
Ability to partner and influence key stakeholders on NPD and Lifecycle teams.
Leverages scientific and technical understanding of medical devices to serve as a resource and strategic partner for development and planning throughout the product lifecycle in applicable markets.
Builds, sustains, and rewards a culture of innovative thinking, informed risk taking, intellectual curiosity, and the continual learning of scientific, technological, and Regulatory developments.
Advises and challenges others, including cross functional business partners, to ensure the best business-level best decisions are consistently made within the organization and based on the Credo
Guides internal clients in the application of standards and obtains clarification from regulatory agencies when needed.
Ability to work as a member of a team in a timeline-driven environment with minimal supervision is required.
Connect by cultivating external relationships with regulators in key markets (in partnership with Regions, Policy and EU Strategy leads) and internally collaborating with the R&D, Med Affairs, Clinical Affairs, GSM and other partners.
Shape by anticipating regulatory changes in key markets to maximize patient access to innovative technologies.
Lead by acquiring and developing a diverse team of talented regulatory professionals and transparently communicating in a constructive manner
Deliver by mobilizing and inspiring an accountable team to deliver results for on-time clearances/approvals with a global and enterprise-wide mind-set and balance with strategic and short-term goals