Regulatory Affairs Manager
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Regulatory Affairs Manager, located in Danvers, MA. Remote work options may be considered on a case-by-case basis and if approved by 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/
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential. At Johnson & Johnson, we all belong.
The Regulatory Affairs Manager will be responsible for developing strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices. You will advise on regulatory requirements as a key member of cross-functional teams, prepare and review FDA submissions, and interact with and respond to FDA pre-submission and during the review period. Your core focus will be regulatory leadership for software (both SiMD and SaMD) and hardware development and changes. Through your engagement in this role, you will help shape the life-saving field of heart recovery.
The ideal candidate will:
- Have Regulatory Affairs experience in the medical device industry with a track record of successful FDA submissions that include software and hardware components
- Be passionate about Regulatory Affairs impact in support of the research, development, clinical, marketing, and production of state-of-the-art class III cardiovascular medical devices
- Be energized by joining a world-class company and regulatory team
- Enjoy teamwork and thrive as a member of dynamic cross-functional teams
- Build and maintain strong interpersonal relationships within and outside of the company
- Exhibit leadership traits- positive, forward looking, accountable, action-oriented, delivering results
- Be adaptable and thrive in a dynamic work environment where variety is the routine.
- Embrace change, continuous learning, and work skills improvement
Key Responsibilities:
- Independently support cross-functional new product development projects with a specific focus on software (both SiMD and SaMD) and hardware aspects, and lead compilation of all materials required for submissions to FDA
- Provide ongoing support to project teams for regulatory issues and questions. Find, interpret and apply regulations and guidance appropriately for situations
- Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance
- Provide support for changes to existing products, including providing regulatory assessment of changes and subsequent regulatory filings
- Develop solutions to a variety of technical problems. Actively participate in problem solving discussions and recommend solutions
- Keep abreast of FDA guidance documents and regulations and monitor impact of changing regulations on submission strategies
- Assist in the maintenance and improvement of regulatory SOPs
- Interact and negotiate with regulatory agencies on defined matters as needed
