Regulatory Affairs Specialist - Danvers, United States - Johnson & Johnson

Description

Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a 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 Regulatory Affairs Specialist will be responsible for preparing regulatory documents and submissions according to Abiomed standards. You will work closely with Regulatory Affairs team members and cross-functional staff members to support Regulatory programs. Through your engagement in this role, you will help shape the life-saving field of heart recovery.


The ideal candidate will:

• 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
• Adaptable and thrive in a dynamic work environment where variety is the routine.
• Embrace change, continuous learning, and work skills improvement

Key Responsibilities:

• Prepare FDA submissions and other regulatory documents including 510(k)s, IDEs, Qsubs, PMA Supplements, PMA Amendments, and PMA Annual Reports
• Create, review and approve engineering changes and make reportability decisions per FDA guidance documents
• Actively participate on project teams, review and approve protocols and reports to support regulatory submissions
• Review relevant guidance documents and provide interpretative assistance for new filings
• Communicate regulatory plans and project status to internal stakeholders