Manager, Regulatory Affairs - Abiomed, Inc.

Company: Disability Solutions
Location: Danvers
Posted on: February 5, 2025

Job Description:

Abiomed, part of Johnson & Johnson MedTech, is recruiting for a Regulatory Affairs Manager. The preferred location for this role is within a commutable distance of Danvers, MA however remote work options may be considered on a case-by-case basis.\rAbout Johnson & JohnsonAt 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/.\rThe 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.\rThe ideal candidate will:

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• 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\r\rKey Responsibilities:
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  • 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.\r\r

Keywords: Disability Solutions, Billerica , Manager, Regulatory Affairs - Abiomed, Inc., Executive , Danvers, Massachusetts