Regulatory Compliance Manager

Hispanic Technology Executive Council; United States; On-site; USD 103,000 - 148,000; Full time

Job summary

A leading company in the healthcare sector is seeking a Regulatory Compliance Manager to oversee global compliance strategies for medical products. This remote position requires strong regulatory affairs expertise, with responsibilities including policy development, compliance monitoring, and stakeholder engagement. The ideal candidate will possess a Bachelor's degree and significant experience in regulatory compliance, particularly in the medical device industry.

Benefits

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Flexible spending accounts (FSAs)

Short- and long-term disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Qualifications

• Minimum of 5 years of relevant experience in regulatory affairs.
• Proficiency in global medical devices, environmental and sustainability regulations.
• Ability to travel up to 25%.

Responsibilities

• Identify and monitor global healthcare regulations impacting GMPD products.
• Develop and maintain compliance programs and internal policies.
• Prepare and present compliance reports to senior management.

Skills

Organizational skills

Problem solving

Critical thinking

Negotiation skills

Communication skills

Education

Bachelor's degree in scientific or compliance field

Job description

What Regulatory Compliance contributes to Cardinal Health

Regulatory Compliance develops and implements strategies and standard operating procedures to promote the companys adherence to relevant laws, regulations, and internal policies, includingmonitoring for compliance and development and implementation of comprehensive compliance programs impacting GMPD products.

Job Summary

In line with Cardinal Health business objectives, the Regulatory Compliance Manager will assist with managing Global regulatory compliance across Global Medical Products and Distribution (GMPD) that includes identification and monitoring of relevant standards and regulations pertaining to Cardinal Health products and services in key markets globally, and development comprehensive regulatory compliance execution strategies. The selected candidate will play an essential role in fostering trusted engagement with external regulators, industry associations, patient advocacy groups, and internal Cardinal Health stakeholders to develop, influence and lead the development of internal and external regulatory policies.

Leverage broad knowledge of regulatory affairs, quality management systems and business operations to develop regulatory strategies utilizing the least burdensome execution approaches, making risk-based decisions while achieving regulatory compliance and business goals, maintaining compliance integrity across the GMPD and prioritizing workload to best achieve desired end state.

This is a 100% remote position but will require regular travel to Mansfield, MA, Waukegan, IL, Dublin, OH and Hazelwood, MO. The ideal candidate would be located close to one of these facilities.

Responsibilities

• Identify, monitor, and interpret global healthcare and environmental regulations impacting GMPD products and product-related processes for efficient, cost-effective and compliant support of global operations, including import and export, through clear & consistent assessment of regulatory requirements and development of streamlined compliance execution strategies while helping to mitigate regulatory, legal and financial risks for the business and ensure business continuity of Cardinal Health products and services.
• Develop and maintain comprehensive and timely compliance programs and internal policies and procedures and that align with regulatory requirements throughout the product lifecycle, from design and development to end of life activities.
• Represent Cardinal Health in interactions with relevant regulatory authorities and 3rd party vendors on matters related to regulatory strategies and global compliance execution and act as a point of contact for regulatory agencies.
• Respond to inquiries and requests, both internal and external.
• Develop and deliver training programs for employees to ensure awareness and understanding of relevant regulations.
• Prepare and present compliance reports to senior management (including, but not limited VP, SVP, GM/CEO level), highlighting key risks and proposed mitigation solutions.
• Manage and maintain accurate and complete regulatory documentation of compliance activities.
• Identify and resolve compliance issues, develop and implement corrective actions and identify opportunities for improvement in compliance programs and processes.

Qualifications

• Bachelor's degree in scientific or compliance field, e.g., Legal, Regulatory Affairs, Engineering discipline, or equivalent work experience, preferred
• Regulatory Affairs experience in Medical Device industry
• Minimum of 5 years of relevant experience
• Proficiency in global medical devices, environmental and sustainability regulations
• Strong organizational skills
• Ability to multitask and manage multiple projects
• Negotiation skills
• Deadline conscious
• Problem solving skills
• Critical thinking
• Strong oral and written communication skills
• Ability to travel up to 25%

What is expected of you and others at this level

• Stay current with and maintain a good understanding of evolving global regulatory requirements.
• Apply advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
• Participate in the development of policies and procedures to achieve specific goals
• Recommend new practices, processes, metrics, or models
• Work on and lead complex projects of large scope
• Projects may have significant and long-term impact
• Provide solutions which may set precedent
• Independently determine method for completion of new projects
• Receive guidance on overall project objectives
• Act as a mentor to less experienced colleagues

Anticipated salary range:$103,500 - $147,900

Bonus eligible:Yes

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

Application window anticipated to close:6/20/2025 *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 candidates geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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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.