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.
EDUCATION/ TRAINING and/ or EXPERIENCE:
· Masters Degree or Equivalent.
· Requires 10 - 15 years related experience, predominantly in Regulatory with a minimum of five within the therapeutic space. Must have taken product through the complete regulatory cycle (development to commercialization).
· PMA experience required and Class I, II and III Medical Device experience.required
· International Regulatory experience in EMEA, APAC and LATAM regions preferred.
· Can work in a fast paced environment.
· Significant management and people management is required.
· Strong interpersonal communication skills.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
· Ability to use PC’s and associated software
Good written and oral English communication skills required
ADDITIONAL POSITION REQUIREMENTSInclude whether or not position will be required to work in clean room, near or with heavy machinery, ability to lift heavy objects, ability to wear protective gear in lab, etc
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually quiet.
Travel required (approximately 35%), predominantly US and EU in nature.
Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The above statements are intended to describe the general nature and level of the 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.
Contact the job poster
Amanda Pelletier, CIR
Senior Recruiter, Global Executive Search at Cardinal Health
Cardinal Health, Inc. is a global, integrated healthcare services and products company, providing customized solutions for hospitals, healthcare systems, pharmacies, ambulatory surgery centers, clinical laboratories and physician offices worldwide. The company provides clinically proven medical products and pharmaceuticals and cost-effective solutions that enhance supply chain efficiency from hospital to home. Cardinal Health connects patients, providers, payers, pharmacists and manufacturers for integrated care coordination and better patient management. Backed by nearly 100 years of experience, with approximately 50,000 employees in nearly 60 countries, Cardinal Health ranks #15 on the Fortune 500. For more information, visit cardinalhealth.com, follow @CardinalHealth on Twitter.