ICU Medical Inc.

Senior Associate, Regulatory Affairs (Hybrid - Lake Forest, IL)

ICU Medical Inc. • $95K — $115K *
Lake Forest, IL 60045Hybrid
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering, or related field required; master's or Ph.D. preferred
  • Over seven years of experience in the Medical Products Industry; at least three years in Regulatory Affairs
  • RAC Certification preferred to validate regulatory expertise
  • Proven ability to lead scientific arguments and apply analytical reasoning
  • Strong project management, critical thinking, and negotiation skills

Responsibilities

  • Provide regulatory advice and support to product teams, identifying registration needs and strategies
  • Plan and organize registration packages according to local regulatory requirements
  • Serve as a liaison with regulatory agencies, assisting in agency meeting preparations
  • Evaluate manufacturing and labeling changes for regulatory impact and communicate accurately
  • Represent Global Regulatory Affairs at research and development meetings, presenting regulatory strategies

Benefits

  • Professional development opportunities to enhance regulatory expertise
  • Engagement with cross-functional teams, providing a collaborative work environment
  • Potential for exposure to diverse regulatory challenges on a global scale
  • Travel opportunities for agency interactions and compliance assessments
Full Job Description
Job Description

Position Summary

Provides regulatory support and expertise associated with global and US registration of device electro mechanical products, including in-depth analysis of the requirements and tracking of deliverables. With oversight, supports creation of global regulatory strategies and assists in execution including creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management.

Essential Duties & Responsibilities
  • Provides regulatory advice and support to assigned products/teams. Identifies and communicates registration needs and strategies. Maintains awareness of applicable regulations.
  • Plans and organizes registration packages for device products. Prepares registration packages in line with local regulatory requirements and guidelines.
  • With oversight, serves as a liaison with regulatory agencies pertaining to assigned products. Assists in the preparation of agency meeting packages and strategies for agency meetings.
  • Evaluates manufacturing and labeling changes for regulatory impact. Accurately describes these changes for ease of regulatory agency review.
  • Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review.
  • Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team.

Knowledge & Skills
  • Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission.
  • Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
  • Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles.
  • Define and negotiate regulatory strategy with supervision.
  • Exercise good judgment within policy and regulations.
  • Responsible for tracking and completion of assigned registration activities.
  • Accountable for accuracy of work and meeting multiple, simultaneous deadlines. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letter.
  • Follows scientific arguments, identifies regulatory scientific data needs and solves regulatory issues with alignment of regulatory management.
  • Presents scientific data effectively orally and in writing in a logical and persuasive manner.
  • Provides daily regulatory support to new product development teams and commercial support with guidance.
  • Participates in preparing regulatory strategies. Reviews submissions, regulatory commitments, strategy decisions, and changes to resource allocations with manager prior to execution.
  • Acts independently on all routine issues, makes judgment and executes.


Minimum Qualifications, Education & Experience
  • Must be at least 18 years of age
  • High School Diploma required
  • Bachelor's degree from an accredited college in pharmacy, biology, chemistry, pharmacology, engineering or related subject or university is required
  • Master's Degree or P.H.D preferred
  • RAC Certification preferred
  • Seven plus years of experience in Medical Products Industry with a minimum of 3 years of experience in Regulatory Affairs.
  • Able to lead scientific arguments and apply analytical and logical reasonings.
  • Ability to effectively prioritize workload and multitask with minimal supervision.
  • Good interpersonal skills.
  • Good oral and written communications skills.
  • Demonstrated project management skills.
  • Demonstrated critical thinking, contingency planning and negotiating skills.
  • Understanding of regulatory and business needs with ability to establish direction and influence cross functional team members.

Work Environment
  • This is largely a sedentary role.
  • This job operates in a professional office environment and routinely uses standard office equipment.
  • Typically requires travel 5-20% of the time


About ICU Medical Inc.

ICU Medical, Inc. is a global medical device company that develops, manufactures, and sells innovative medical products used in vascular therapy, oncology, and critical care applications. The company's products are designed to improve patient outcomes by helping prevent bloodstream infections and protecting healthcare workers and patients from exposure to infectious diseases or hazardous drugs. ICU Medical's product portfolio includes needlefree connectors, closed system transfer devices, and other medical devices and accessories. The company has operations in North America, Europe, and Asia and employs over 5,100 people worldwide.
Learn more about ICU Medical Inc.
Size
8,500 employees
Market Cap
$3.7 billion
Industry
Healthcare
Net Income
$86.8 million
Founded
1984
5 Year Trend
+28.3%
Revenue
$1.2 billion
NASDAQ
ICUI
* Ladders Estimates

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