The Regulatory Affairs Specialist will prepare global regulatory documents and submissions according to Abiomed standards. 

Primary Duties and Responsibilities:

• Participate in internal or external audits
• Maintain company registration and device listings for global regulatory agencies
• Coordinate efforts associated with the preparation of regulatory documents and submissions for FDA, Health Canada, Notified Bodies, PMDA and ROW countries
• Maintain current knowledge base of existing and emerging regulations, standards and guidance documents
• Identify relevant guidance documents, international regulations and standards and provide interpretive assistance for new filings
• Communicate with regulatory agencies regarding clarification of or follow-up of submissions under review
• Prepare and maintain technical files as necessary to obtain and sustain product approvals
• Compile and maintain regulatory documentation databases and tracking systems

Job Qualifications:

• BS degree or equivalent with additional courses or seminars in Regulatory Submissions
• 5+  years related experience in Regulatory Affairs within the medical device industry
• Ability to Communicate ideas and information clearly, effectively and frequently (oral and written)
• Execute tasks in a timely manner with general supervision
• Must have excellent communication and organizational skills
• Able to prioritize tasks
• Must be proficient in Microsoft Office Suite
• Computer competency and ability to function within an environment that relies heavily on technology for information and communication is required

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.