Principal Regulatory Affairs Specialist

Cardinal Health; Madison (WI); Remote; USD 79,000 - 120,000; Full time

Job summary

An established industry player is seeking a Principal Regulatory Affairs Specialist to join their dynamic Medical Solutions team. This role is crucial for supporting the regulatory aspects of medical device projects, ensuring compliance with US and international regulations. The ideal candidate will leverage their extensive experience in regulatory affairs to lead product development initiatives and collaborate with cross-functional teams. With a focus on innovation and compliance, this position offers a unique opportunity to impact the medical device landscape positively. Join a forward-thinking company that values diversity and encourages professional growth.

Benefits

Medical Coverage

Dental Coverage

Vision Coverage

Paid Time Off

Health Savings Account (HSA)

401k Savings Plan

Flexible Spending Accounts (FSA)

Short- and Long-term Disability Coverage

Work-Life Resources

Paid Parental Leave

Qualifications

• 5-7 years of Regulatory Affairs experience in the Medical Device industry.
• Proficiency in US and Europe medical device regulations.

Responsibilities

• Lead new product development projects and integrate regulatory strategy.
• Prepare and maintain global product registrations focusing on 510(k) and EU Technical Documents.

Skills

Regulatory Affairs

Medical Device Regulations

Project Management

Communication Skills

Organizational Skills

Education

Bachelor’s Degree in a Scientific Discipline

Equivalent Work Experience

Job description

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

_Qualifications:_

+ 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

+ Strong organizational skills

+ Ability to manage multiple projects

+ Team oriented

+ Strong oral and written communication skills

Anticipated salary range : $79,700 – $119,490

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

Application window anticipated to close: 5/2/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidate’s geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

#LI-MP1

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_Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply._

_Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. 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._

_To read and review this privacy notice click_ here (https://www.cardinalhealth.com/content/dam/corp/email/documents/corp/cardinal-health-online-application-privacy-policy.pdf)

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