Abiomed
Associate Director, Regulatory Affairs
Job#: 17RA-01
Positions: 0
Posted: 03/21/2017
Job Type: Full Time
Location: Danvers, MA
Department: Regulatory Affairs
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Job Description

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
  • Excellent problem solving skills
  • Advanced people management skills
  • Positive flexible outlook
  • Excellent interpersonal communication skills
  • Works effectively on cross-functional teams
  • Presents professional manner and appearance
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