Senior Regulatory Affairs Specialist

Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist .

Remote work options may be considered on a case-by-case basis and if approved by the Company

Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices that provide circulatory and respiratory support, with a mission of recovering hearts & saving lives.

Abiomed's "Patients First!" culture drives our skilled workforce and strong relationships with clinicians.

Our innovative product portfolio and robust pipeline provide us the incredible opportunity to bring lifesaving technology to more patients around the world than ever before.

Founded in 1981, Abiomed has a proven track record for growth, integrity and innovation.

The Senior Regulatory Affairs Specialist 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 support 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:

• 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 parti...