The Associate Director of Regulatory Affairs is responsible for planning and implementing policies, procedures, practices and strategy for the regulatory functions. This position reports directly to the Senior Vice President of Global Quality, Regulatory and Clinical Operations. This person manages Regulatory Affairs staff in addition to oversight responsibility for Regulatory consultants. This position coordinates departmental planning, manages multiple project teams and provides the regulatory strategies to ensure appropriate implementation of key business initiatives. The position requires acting as the liaison with the FDA and other global regulatory agencies with responsibility for global regulatory submissions.
Principle Duties and Responsibilities:
Develop and implement regulatory strategy and manage those systems and programs in order to meet corporate goals and objectives
Coordinate department planning to ensure that the Regulatory Department functions optimally and within the budget
Prepare and review FDA applications and other regulatory documents including 510(k)s, PMAs, Investigational Device Exemptions (IDE) and Humanitarian Device Exemptions (HDE)
Review and advise on 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 all product labeling and marketing materials to ensure compliance with regulatory requirements
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 or cross-departmental initiatives
Coach Regulatory managers with all aspects of their responsibilities
Participate in the short and long range planning of new product opportunities
Provide management-level representation during internal and external GCP audits
Oversees the Regulatory Department SOP review and development, employee training and associated requirements
Maintain knowledge of competitive technologies in addition to medical, technical and biomedical associated requirements
Regularly make presentations to senior staff members
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
Actively work to promote team building and morale within the department
Skills/Requirements
Bachelor degree in engineering, biological sciences or related medical/scientific field
Certificate in Regulatory Affairs preferred
Prepared a PMA or PMDA
Minimum of 7 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 4 years' management experience
International regulatory experience desirable, including Japan, Asia and U.K.
Proven ability to work in a matrix environment
Excellent written and oral communication skills
Proficient knowledge of medical terminology
Expertise with FDA and OUS regulations, in particular Japan, GCP and international regulatory compliance guidelines for clinical trials and proven track record in similar role
High attention to detail and accuracy
Able to manage multiple project teams
Excellent prioritization and organizational skills