Regulatory Affairs Project Manager
Regulatory Affairs Project Manager
- Great Place to Work® Certified - 2024
- Competitive salary package, flexible work practices, award winning benefits
- Continuous training and development
ABOUT THE COMPANY
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
As part of Johnson & Johnson, Abiomed is an innovative and fast-growing medical technology business with a core mission of “Recovering hearts. Saving Lives” in Cardiac. This new position is an exciting opening for you to join the team and enjoy a rewarding and challenging career!
THE OPPORTUNITY
As Regulatory Affairs Project Manager you are responsible for overseeing the submission of new product applications to regulatory agencies, ensuring compliance with relevant guidelines and protocols. Your role will involve directing and coordinating activities related to product approvals, guiding teams on regulatory compliance issues and maintaining regulatory submissions and files. Additionally, you will collaborate with management to establish strategies and prepare regulatory filings and working closely with the global team.
RESPONSIBILITIES
- Develop and oversee regularity strategies that align with company goals
- Apply deep knowledge of regulations, laws, and guidelines to ensure compliance
- Understand the scientific and technical aspects of the medical device products
- Manage projects to meet deadlines and budget requirements by coordinating resources
- Guide stakeholders and colleagues in making key decisions by evaluating risks and benefits
- Create string negotiating positions to gain support from stakeholders
- Engage cross functional teams through thoughtful questions and ensure mutual understanding in discussions
