Director, Reg Affairs - 100312 - San Jose,CA - 0500 Posted Date: August 22, 2013



Job Description

Director, Reg Affairs

Purpose Statement:

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.
 
Key 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.
·          Directs and coordinates the integration of acquired companies ensuring compliance and optimal achievement of business objectives.
·          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.
 
Quality System Requirements:
 
In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
For those individuals that supervise others, the following statements are applicable:
·          Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
·          Establishes and promotes a work environment that supports the Quality Policy and Quality System.
 
Management Requirements:


·          May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
·          Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
·          May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
·          Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Experience Required

Qualifications:· Bachelor?s degree, Advanced degree preferred· 8 + years management experience in Reg Affairs required· Experience in Electrophysiology, particularly ablation, mapping or cardiac device experience preferred· Class II and Class III medical device experience required· Experience working with notified bodies for CE Marking required· Experience with IDE?s (Investigational Device Exemption) desired· Experience with original PMAs desired· Experience with FDA panel desired· Successful experience leading and managing a team· Ability to work cross-functionally with Operations, Clinical, PMO, R&D, Quality and Manufacturing· Demonstrated ability to manage company integrationThe above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.