The Director of Regulatory Affairs is responsible for planning and implementing global policies, practices and strategy for the regulatory functions. This position reports directly to the Senior Vice President of Global Quality, Regulatory and Clinical Operations. This position leads all global departmental planning, manages multiple project teams and provides the regulatory strategies to ensure appropriate implementation of key business initiatives. The position acts as the primary liaison with the FDA and other global regulatory agencies with responsibility for global regulatory submissions. The Director position provides the Regulatory Department interface to executive management and is seen as one of the top leaders in Abiomed.
Principle Duties and Responsibilities:
Lead, develop and implement regulatory strategy in order to meet corporate goals and objectives
Prepare and/or review FDA applications with your team including 510(k)s, PMAs, Investigational Device Exemptions (IDE) and Humanitarian Device Exemptions (HDE)
Lead international product registration and licensing 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
Ensure that the Regulatory Department interfaces with key functional groups (R&D, Manufacturing, Sales, Marketing, Quality Assurance and Field Clinical Groups) to drive company-wide initiatives
Coach and develop Regulatory team with all aspects of their responsibilities
Contribute to the short and long range planning of new product opportunities
Maintain knowledge of competitive technologies related to Abiomed products
Make presentations to senior management
Procure and oversee outside vendors and consultants, as required
Establish and maintain a professional and credible image with key physicians, consultants, vendors and co-workers
Skills/Requirements
Job Qualifications:
Bachelor degree in engineering, biological sciences or related medical/scientific field. M.S. preferred
Certificate in Regulatory Affairs preferred
Minimum 10 years regulatory experience in the medical device industry, with proven track record of successful submissions to FDA of IDEs, 510(k)s and PMAs
At least 5 years management experience
Up to date international regulatory knowledge experience needed , especially Japan
Proven ability to work in a matrix environment
Excellent written and oral communication skills
Proficient knowledge of cardiovascular system and terminology
Familiarity with clinical research study design
High attention to detail and accuracy
Excellent problem solving skills
Positive flexible outlook
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.
