The Senior Manager, Regulatory Affairs will be responsible for all regulatory submissions and act as a key liaison with the international regulatory bodies of Asia Pacific and rest of world (ROW) regions. The ideal candidate will:

• Be passionate about regulatory affairs leadership in support of the production of state-of-the-art medical devices
• Be energized by working for a world-class manufacturer and collaborating on cross-functional teams
• Recognize the importance of building and maintaining strong interpersonal relationships

Principle Duties and Responsibilities:

• Drive regulatory planning and ensure alignment with business and functional goals and priorities
• Provide leadership to develop and implement regulatory strategies throughout the product lifecycle that are consistent with business unit goals and objectives
• Prepare and review PMDA applications and other regulatory documents for ROW authorities
• Prepare and review applications to regulatory agencies
• Conduct presentations and negotiations to agency reviewers as needed
• Review and approve Clinical Investigational Plans and Institutional Review Board submissions as needed 
• Deliver international product registration and licensing requirements
• Review and interpret regulatory rules as they relate to company products and procedures, clinical studies, testing or records keeping and ensure that they are communicated through company policies and procedures
• Review and approve all changes to manufacturing processes and products to ensure compliance with RA and QSR guidelines
• Provide input to the product development and engineering teams to ensure that RA requirements are fully understood and mitigated as part of the product development and the engineering change process
• Manage and mentor junior RA staff members to become self-sufficient in efficiently completing their RA tasks 
• Communicate regulatory project status to internal stakeholders
• Advocate for the Regulatory Team with internal stakeholders
• Interact with and influence external regulatory agencies and trade associations
• Work without outside regulatory consultants on ROW applications
• Collaborate with design and development teams on regulatory strategies for programs

#LI   Job Qualifications:

• Advanced degree in engineering or science (or equivalent in experience) required
• 7 years of regulatory affairs experience with a cardiovascular device company preferred
• Solid experience and proven track record in successful submissions for Asia Pacific and ROW regions
• Exhibited strong project management and leadership skills
• Ability to Communicate ideas and information clearly, effectively and frequently (oral and written)
• Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results
• Ability to act independently to determine methods and procedures
• Must be proficient in Microsoft Office Suite

ABIOMED is an Equal Employment Opportunity/Affirmative Action employer.  We are committed to the policy of providing equal employment opportunities without regard to race, color, religion, sex, sexual orientation, gender identity, veteran status, disability or national origin.