The Sr.Regulatory Affairs (RA) Program Manager will prepare FDA and international regulatory submissions and will act as a key liaison with the FDA, Health Canada and other global regulatory bodies.
Principle Duties and Responsibilities:
Develop strategies and tactics to obtain FDA regulatory product approvals
Prepare and review FDA applications and other regulatory documents including 510(k)s, PMA’s, Investigational Device Exemptions (IDE), Humanitarian Device Exemptions (HDE), Humanitarian Use Device (HUD) Applications and Periodic Medical Device reports
Prepare and review other international applications to regulatory agencies including Health Canada and other ROW countries’ regulatory bodies
Conduct presentations and negotiations to FDA reviewers or other regulatory 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
Establish effective communication with executives and managers to ensure that regulatory requirements are met
Enhance and sustain positive relationships with the FDA and other international agencies
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
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
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.
