Job description

Job / Position Title

Director of global REGULATORY AFFAIRS

Functional Área / Department

REGULATORY

Supervisor Job Title

Svp, REGULATORY and quality

SUMMARY OF THE JOB:  Summarize the overall purpose of the position.

Manages the coordination, compilation and submission of all medical device applications; including new product development activities and base business regulatory compliance, to the regulatory agencies in the Global markets assigned to area of responsibility.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Accountable for the development and execution of regulatory strategies that are risk appropriate in markets assigned to area of responsibility.
• Leads the Regulatory Affairs department with headquarters based in the U.S.
• A strong technical understanding of the Cordis product portfolio and the positioning of Cordis product within the cardiovascular and endovascular therapeutic areas.
• Collaborate with project team members to plan and coordinate regulatory submissions in support of ongoing and future global clinical studies and those regulatory applications meet regulatory requirements for their given markets.
• Tactically support Regulatory Affairs staff with workload as needed.
• Monitors the regulatory environment globally and provides assessments of the impact of new and changing regulations on the company's research and development programs to senior management.
• Establishes standard operational procedures to achieve efficiency within the regulatory affairs department, including interfacing with other departments to coordinate the development of regulatory procedures and controls to ensure product compliance in a timely manner.
• Provides Regulatory guidance and oversight to R&D and manufacturing to assume responsibility for compliant product throughout the product development life cycle management as related to iterative product and change control.
• Provides support to senior management of the Regulatory staff development and budget to support business objectives.
• Collaborates with the management team in establishing short and long term strategic goals and directs implementation to achieve objectives.
• Establishes learning initiatives and training of Regulatory staff on current and emerging regulatory and related requirements.
• Supports an environment of individual contribution and team collaboration as both being important and empowers staff with talent management.
• Provides Regulatory guidance on regulatory issues related to advertising, promotion, labeling, corporate and public disclosures/ communications, and ensuring alignment with Health Care Compliance and Regulatory Legal business partners.
• Responsible for communicating business related issues or opportunities to next management level.
• For employees with supervisory responsibilities, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures including all markets globally.
• Responsible for ensuring compliance with Quality Procedures, Laws and Regulations of the applicable Global markets.
• Performs other duties assigned as needed.