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 for Director of Regulatory Affairs 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
Purpose of this role:
The Director of Regulatory Affairs is responsible for regulatory activities of the Neurovascular product portfolio, including ensuring the preparation of appropriate regulatory strategies and submissions to obtain & maintain marketing authorizations from the relevant governmental agencies, by performing the following duties personally or through their staff.
What you will be doing:
- Build and maintain relationships in the Neurovascular sector, make decisions and recommendations for assigned regulatory submissions worldwide.
- Set the strategic regulatory framework for pipeline development and global product launches within the neurovascular portfolio.
- Support the Clinical team in the development and roll out of clinical trials and early feasibility studies.
- Partner with R&D, Global Strategic Marketing, Supply Chian, Clinical and the other functions to develop the strategies to support pipeline development and support global launches of the neurovascular devices.
- Lead and develop a regulatory team and cultivate future leaders.
- Works closely with trade associations and professional committees to influence medical device legislation & regulation.
- Represents the company at industry-wide regulatory activities.
- Assures compliance with worldwide product registration, notification, or premarket approval requirements. This is accomplished through the management of procedures, reviews and approvals.
- Reviews promotional and advertising materials for compliance with applicable requirements.
- Interfaces directly with the FDA on regulatory matters and with other regulatory agencies as required.
- Provide continuing regulatory education and dissemination of regulatory information to other functional groups within the organization.
- Responsible for communicating business related issues or opportunities to next management level
- Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
What you will bring:
- Bachelor’s Degree in Physical or Biological science or related field of study, advanced degree preferred.
- Strong level of relevant leadership experience.
- Direct experience in obtaining FDA approval/clearance of PMAs, 510(k)s, and IDEs required.
- Neurovascular and/or High-risk medical device experience desirable.
- International regulatory experience, including experience in submitting and obtaining worldwide product marketing approvals required.
- Management experience required, including management of direct reports and external consultants.
- Excellent written and oral English communication skills.
- Excellent negotiation skills required.
- Cross-cultural awareness skills desirable.
- Impeccable integrity essential.
- Strong goal-orientation with a high energy level required.
- Travel: 15%
- Occasional weekend/travel work may be required as necessary.
Location and travel requirements:
- Location: Galway, IE
- Travel: 15% travel, both domestic and international
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