Regulatory Affairs Manager (Hybrid)

Position Summary 

Manages the Regulatory Operations team responsible for various operational regulatory activities. Oversee the preparation, review and submission of data and documentation to support regulatory applications, product registrations.  Establishes and manages systems and processes to support publishing of regulatory submission packages, product and facility registrations and regulatory data management.

Provides regulatory support and expertise by developing global regulatory strategies, identifying needed registration data, obtaining this data and ensuring that it is effectively presented for the registration of products. May serve as a lead regulatory representative to an assigned product or project team.  Interacts with various regulatory agencies and internal ICU Medical cross functional organizations.

Essential Duties & Responsibilities

• Provides regulatory advice and support to assigned software products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
• Plans and organizes software registration packages. Timely and accurate preparation of registration packages in line with local regulatory requirements and guidelines
• With oversight, serves as a liaison with regulatory agencies pertaining to assigned products/teams. Assists in the preparation of agency meeting packages and strategies for agency meetings.
• Evaluates product and labeling changes for regulatory impact with guidance.  Accurately describes these changes for ease of regulatory agency review.
• Represents Global Regulatory Affairs at project meetings. 
• Manages Regulatory Operation processes and drives continuous improvement by facilitating, leading, and collaborating with cross functional teams. 
• Manages publishing activities for US, EU and Canada device submissions to ensure timely registrations and product launches.
• Ensures U.S. CFG requests and facility registration are processed timely.
• Provides support for drug submissions as needed.
• Establishes and maintains system for management of regulatory data.
• Identifies, develops, validates and maintains Regulatory Operations systems and software with coordination with IT when applicable.
• Represents Regulatory Affairs for areas assigned for regulatory agency interactions (either written or oral) including internal and external audits, and inspections.
• Ensures that Regulatory Operations resources are optimized and working in an efficient manner.
• Effectively manages others in the accomplishment of tasks and collaborates with others to ensure success. 
• Performs other duties as assigned or required.

Knowledge, Skills & Qualifications

• Able to follow scientific arguments.
• Good interpersonal skills.
• Developing negotiating skills.
• Exceptional interpersonal skills; professional demeanor and attitude
• High level of attention to detail
• Understands the key requirements in the submission development process to facilitate regulatory submission publishing.
• Demonstrate the proven capability to define, plan, and execute projects involving a diverse cross-functional team within the established boundaries of quality, time and budget.
• Excellent verbal and written communication skills.
• Strong understanding of business needs.
• Must have strong experience with word-processing, spreadsheet, presentation and other document publishing software.

Minimum Qualifications, Education & Experience 

• Must be at least 18 years of age.
• Bachelor’s degree from an accredited college or university is required.
• Minimum eight years of experience in Medical Device, or regulated industry, specifically three years in Regulatory Affairs
• Minimum of two years’ management experience 
• Experience with Regulatory inspections and successful track record

Work Environment

• This is largely a sedentary role. 
• This job operates in a professional office environment and routinely uses standard office equipment.
•  Requires minimal travel <5% of the time.

Salary Range - $112,500 - $161,250

The salary range displayed represents the annual base salary we reasonably expect to pay for this role.  The actual salary may vary [differ] based upon various factors, including, but not limited to, relevant experience, skills, education, licensure/certifications, and geographic location.

 ICU Medical provides a comprehensive total rewards package that includes:

• Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
• A wide range of benefit options at affordable rates
• Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement

 Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/.

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. 

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [email protected]. We are committed to providing equal access and opportunities for all candidates.