Cardinal Health
Director, Regulatory Affairs
At a glance
Location: US-MA-Mansfield Map
Posted: 12/08/2019
Closing: 01/07/2020
Degree: Not Specified
Type: Full-Time
Experience: Not Specified
Cardinal Health
Job description

The Director Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.


Accountabilities

  • Deliver innovative regulatory strategies and high-quality submissions that produce timely and predictable worldwide regulatory approvals
  • Lead the Regulatory Affairs function for the Patient Recovery business through active participation in functional leadership and decision teams
  • Direct a team of Regulatory Affairs Managers and Specialists in the management of new product development/ modification projects to establish and integrate regulatory submissions strategy into project activities
  • Coach RA team in the preparation of submissions (i.e. 510k, CE Marking applications, technical documentation, global product registrations, STED, etc.) to obtain global regulatory approvals and maintain existing regulatory approvals through letter to file, renewals, change notifications, etc.
  • Determine applicable registration requirements for medical devices in all countries in which products are to be registered
  • Interpret and/or evaluate proposed registration requirements for medical devices and advise impact of such regulations on the company
  • Coordinate complex logistical details including team resourcing and project timeline planning; liaise with functional group representatives
  • Manage and/or oversee communication and submission processes of global registrations including general correspondence, reports, and amendments
  • Coordinates submission issues interdepartmentally to ensure compliance and quick and complete resolution
  • Support Cardinal Health domestic and international manufacturing facilities with foreign government and regulatory body inspections
  • Coordinate international registration and appropriate export application forms for Patient Recovery products intended for foreign exportation
  • Review device labeling and advertising materials for compliance with regulations
  • Maintain proficiency on global regulatory requirements; develop and maintain rapport with regulatory reviewers and project team members
  • Plans and implements regulatory policies, procedures, systems, practices, and strategy as required
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies
  • Travel is required up to 15%

Qualifications

  • Bachelors and Advanced degree in scientific field
  • 10+ years experience in global regulatory affairs in medical devices, particularly in the  EU 
  • Prior supervisory experience 
  • QMS experience a plus
  • Effective management and team leadership skills
  • Effective team building skills
  • Ability to create cross-functional partnerships
  • Effective negotiation skills
  • Ability to work collaboratively in a team environment
  • Effective oral and written communication skills
  • Ability to manage critical decision-making
  • Effective problem-solving skills

What is expected of you and others at this level

  • Build/lead/coach a team of regulatory professionals
  • Monitor/strategize/navigate evolving global regulatory landscape
  • Budget for future expenditures and manage departmental budget
  • Prepare and execute effective presentations
  • Collaborate with internal cross-functional department leaders
  • Interface with all levels of management and regulatory body representatives
  • Organize and prepare regulatory filings
  • Review change control documents and ascertain regulatory impact
  • Act as liaison with Cardinal Health Regional RA to address questions and issues that arise as part of the registration and or testing process
  • Recommend strategies based on current local registration requirements and applicable industry standards
  • Drive process and system improvements

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Director, Regulatory Affairs