Regulatory Affairs Specialist II

2 weeks ago

Lake Forest, Illinois, United States ICU Medical Full time
Position Overview


The role involves providing essential regulatory support and direction related to the global and US registration of medical device products. This includes analyzing regulatory requirements and monitoring deliverables.

Under supervision, the position aids in the implementation of global regulatory strategies and contributes to the development and upkeep of global registration documentation. Ensures complete regulatory adherence of all materials for submissions and modifications.

Key Responsibilities

  • Facilitates project progression and implements agreed strategies and plans with guidance. Maintains knowledge of relevant regulations.
  • Organizes and prepares registration submissions for medical device products, ensuring alignment with local regulatory standards.
  • With oversight, interprets and responds to communications from regulatory agencies.
  • Assesses manufacturing and labeling modifications for regulatory implications, clearly articulating these changes for regulatory review.
  • Collaborates with regional and national regulatory counterparts to evaluate changes for compliance and accurately describes these alterations for regulatory agency evaluation.
  • Represents Global Regulatory Affairs in research and development discussions, presenting established regulatory positions. May act as the primary regulatory representative for specific products or project teams.
Knowledge & Skills Required

  • Reviews and approves critical documentation, seeking advice when necessary. Evaluates technical reports for regulatory submission acceptability.
  • Identifies deficiencies in registration documentation and collaborates with team members to resolve issues.
  • Possesses a solid understanding of global regulations to ensure compliance while minimizing development costs and timelines.
  • Develops and maintains regulatory strategies under supervision.
  • Demonstrates sound judgment within established policies and regulations.
  • Responsible for tracking and completing assigned registration tasks, ensuring accuracy and adherence to multiple deadlines. Inaccurate submissions or missed deadlines can lead to delays in regulatory approvals.
  • Follows scientific rationale, identifies necessary regulatory data, and addresses regulatory concerns in coordination with regulatory management.
  • Effectively communicates scientific data both orally and in writing in a clear and persuasive manner.
  • Provides daily regulatory assistance to new product development teams and commercial support with guidance.
  • Participates in the formulation of regulatory strategies, reviewing submissions and regulatory commitments with management prior to execution.
  • Operates with minimal oversight on routine matters, making informed decisions in alignment with regulatory management.
Minimum Qualifications, Education & Experience

  • Bachelor's Degree is required, preferably in pharmacy, biology, chemistry, pharmacology, engineering, or a related field.
  • RAC Certification is preferred.
  • A minimum of three years of experience in the Medical Products Industry, including at least two years in Regulatory Affairs.
  • Ability to evaluate scientific arguments and apply analytical reasoning.
  • Capable of effectively prioritizing tasks and managing multiple responsibilities with minimal supervision.
  • Strong interpersonal skills.
  • Excellent oral and written communication abilities.
  • Demonstrated project management capabilities.
  • Proven critical thinking, contingency planning, and negotiation skills.
  • Understanding of regulatory and business requirements with the ability to engage cross-functional team members.
  • Must be at least 18 years of age.
Work Environment

  • This role is primarily sedentary.
  • Standard office equipment is routinely used.
  • Travel is typically less than 5% of the time.
ICU Medical is an Affirmative Action and Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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