Sr Program Lead Regulatory Affairs

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:

Yokneam, Haifa District, Israel

Job Description:

About Johnson & Johnson MedTech Cardiovascular:

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Regulatory Affairs Program Lead role, to join our team located in Yokneam, Israel.

Purpose: In this role, you will oversee the execution of regulatory strategies and procedures to ensure the release of our products in compliance with regulatory requirements and standards.

You will be responsible for:

Develop and submit regulatory documents to relevant institutions, including the FDA, EU NB's, NMPA, CFDA and other regulatory bodies worldwide.
Support the negotiations and communication with regulators to ensure swift approval of products.
Partner with the R&D via providing clear guidance and instruction to keep products in compliance with regulatory requirements.
Establish policies and standards for new products to ensure global regulatory compliance.
Partner with Clinical Operations to ensure adherence to regulations during clinical trials.
Maintaining TD's , and supporting of US IDE, 510(k), and PMA submissions for medical devices, as well as writing regulatory related documentation supporting successful and creative regulatory strategies and worldwide submissions.

Qualifications and Requirements:

Bachelor's degree in Physical or Biological Science or related field of study. A master's degree is an advantage.
3 years of experience in all aspects of Regulatory Affairs, Quality Assurance or related field.
Proven experience in the Medical Device Industry.
Ability to manage multiple priorities, excellent problem-solving skills, and the capacity to make difficult decisions.
Extensive hands-on experience in activities such as product approval applications, crisis management such as product recalls, FDA inspections.
Strong understanding of Medical Device regulations / standards and Quality principles.

Required Skills:

Preferred Skills:

Analytical Reasoning, Business Writing, Coaching, Collaborating, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking