Company: Boston Scientific
Location: San Jose, CA
Employment Type: Full Time
Wage: yearly
Description:
General Summary:
Responsible for a group of product lines, technology and specialized functions. Primary responsibilities include the identification, development, and implementation of strategic initiatives, franchise structure, and management development.
SPECIFIC DUTIES AND RESPONSIBILITIES:
Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
Directs and coordinates the Regulatory Affairs department and related global submission activities.
Establishes departmental priorities to meet business objectives.
Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives.
Ensures compliance with all relevant regulations and guidelines.
Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation.
Manages relationships with local regulatory agencies and notified bodies.
Partners with Clinical Research to develop the most effective clinical trial strategies and protocols.
Advises divisional management team of prevailing and evolving global regulatory requirements and environment.
Develops, implements, and maintains departmental policies and procedures.
Provides regulatory guidance to divisional MDR reporting function.
Develops and manages departmental budget.
Provides support to corporate regulatory device listing and establishment registration documentation as appropriate.
Coordinates post-market approval activities.
Fosters employee career development.
Participates in trade and professional organizations.
Provides Regulatory Affairs training to manufacturing and development teams.
Provides regulatory support in new business development activities.
Fosters relationships with business partners to ensure regulatory compliance.
Working Conditions
The majority of the work will be spent on site with periodic travel.
Experience:
Position Qualifications
• Bachelor’s degree, preferably in a scientific or technical discipline. Advanced degree preferred.
• Professional regulatory certification(s) preferred.
• 12 years Regulatory Affairs medical industry experience.
• 8 plus years managerial experience.
• Extensive understanding of FDA and global regulations.
• Extensive background in the development of regulatory submissions and documentation.
• Proficient knowledge of clinical trial strategy and study design with good working knowledge of statistical methods and data reporting.
• Excellent grasp of change control and test/validation requirements.
• Strong strategic, decision making, and risk assessment abilities.
• Highly developed written and oral communication, technical writing and editing skills.
• Excellent organizational, leadership, interpersonal and influencing skills.
• Comprehensive understanding of relevant medical procedures, practice, terminology, and products.
• Thorough knowledge of product development process and design control.
Job Code: 27234
Category: Management
Post Date: Wednesday, December 17, 2008 at 9:01 AM
Company: Boston Scientific
Contact Name: recruiter