Principal Regulatory Affairs Specialist

Cardinal Health

12d

About The Position

Cardinal Health is seeking a Principal Regulatory Affairs Specialist to support the Medical Solutions Regulatory Affairs team. The selected candidate will provide regulatory support on a range of medical devices. Job responsibilities include regulatory lead for change development projects, new product development, change assessment, US, EU and international regulatory submissions, commercial support, manufacturing support, compliance related activities, systems improvement, and other responsibilities aligned with global medical device regulations and the goals of the Medical Solutions business. What is expected at this level: Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects May contribute to the development of policies and procedures Works on complex projects of large scope Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives Completes work independently receives general guidance on new projects Work reviewed for purpose of meeting objectives May act as a mentor to less experienced colleagues Responsibilities The Principal Regulatory Affairs Specialist is responsible for the support of new product development and maintenance of business projects. Specific activities include but are not limited to: Lead new and modified product development projects to establish and integrate regulatory strategy into project activities. Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs. Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution Review design control documents including documents associated with design inputs and design outputs Review product labeling for compliance with global labeling regulations Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies Maintain and provide regulatory information in support of customer queries, bid and tender submissions, customs queries, etc. Development and implementation of regulatory procedures and SOPs

Requirements

Bachelor’s Degree in a scientific discipline preferred or equivalent work experience
5-7 years Regulatory Affairs Experience, preferred
Majority of Regulatory Affairs experience in Medical Device industry preferred
You may be expected to travel up to 10% of the time
Proficiency in US and Europe medical device regulations preferred
Strong organizational skills
Ability to manage multiple projects
Deadline conscious
Problem solving skills
Team oriented
Strong oral and written communication skills

Responsibilities

Lead new and modified product development projects to establish and integrate regulatory strategy into project activities.
Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs.
Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution
Review design control documents including documents associated with design inputs and design outputs
Review product labeling for compliance with global labeling regulations
Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business
Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies
Maintain and provide regulatory information in support of customer queries, bid and tender submissions, customs queries, etc.
Development and implementation of regulatory procedures and SOPs

Benefits

Cardinal Health offers a wide variety of benefits and programs to support health and well-being.
Medical, dental and vision coverage
Paid time off plan
Health savings account (HSA)
401k savings plan
Access to wages before pay day with myFlexPay
Flexible spending accounts (FSAs)
Short- and long-term disability coverage
Work-Life resources
Paid parental leave
Healthy lifestyle programs