Principal Regulatory Affairs Specialist

What Reg Affairs Manufacturing FDA contributes to Cardinal Health

Regulatory Affairs Manufacturing (FDA) is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.

SUMMARY OF POSITION:

The Principal Specialist, Regulatory Affairs will be responsible for the support of new product development and maintenance of business projects.

Specific activities include but are not limited to:

• Under direction, support new product development/modifications projects to establish and integrate regulatory submissions strategy into project activities.
• Under direction, prepare submissions (i.e. 510K, CE marking applications, technical documentation, etc.) to obtain domestic filings, European regulatory approvals, and maintain existing regulatory approvals through Letter to File, renewals, change notifications, etc.
• In collaboration with International Regulatory Affairs, determine applicable registration requirements and assist with STED Preparation for medical devices in countries in which products are to be registered.
• Interpret and/or evaluate proposed registration requirements for medical device and advice on impact of such regulations to the company.
• Review device labeling and advertising materials for compliance with regulations and product filings.
• Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.
• Evaluate, develop and implement business process improvements.

ESSENTIAL FUNCTIONS:

• Interface with project teams
• Create and maintain regulatory filings (e.g. product submissions, device listings)
• Review change control documents and ascertain regulatory impact
• Monitor regulatory landscape

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Effective project management skills
• Ability to create cross-functional partnerships
• Effective negotiation skills
• Ability to work collaboratively in a team environment
• Effective oral and written communication skills
• Effective problem-solving skills

MINIMUM REQUIREMENTS:

Education:

• Bachelor’s degree required

Experience:

• 4+  years Regulatory Affairs experience or equivalent required
• Majority of Regulatory Affairs experience in Medical Device industry preferred

Language:

• Fluent in local language required

ORGANIZATIONAL RELATIONSHIPS/SCOPE:

The Principal Specialist, Regulatory Affairs will report into the Manager, Regulatory Affairs for Cardinal Health’s Patient Recovery business.  Interaction with cross-functional Manager, Engineer and Specialist levels will be frequent.  Interaction with management at the Director level and above will be intermittent.

WORKING CONDITIONS:

Travel Time required, up to 10%

What is expected of you and others 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

Anticipated Pay Range: $70,000 to $120,000

Bonus Eligible:  No

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD, etc

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.