The Senior Manager, Regulatory Affairs will be responsible for all submissions for US and Canada and act as a key liaison with the FDA and Health Canada. 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 FDA applications and other regulatory documents including 510(k)s, PMAs, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications and Periodic Medical Device reports
Prepare and review applications to regulatory agencies, including Health Canada
Conduct presentations and negotiations to agency reviewers as needed
Review and approve Clinical Investigational Plans and Institutional Review Board submissions as needed
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 an influence external regulatory agencies and trade associations
Skills/Requirements
#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 FDA successful submissions of 510(k), IDE and PMA
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 #LI-BM1
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.