Regulatory Compliance Specialist II

2 weeks ago

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


The role involves providing regulatory assistance and expertise related to the global and US registration of medical device products. This includes evaluating requirements and monitoring deliverables.

Under supervision, the position supports the implementation of global regulatory strategies and aids in the development and upkeep of global registration documentation. Ensures that all submissions and modifications comply with regulatory standards.

Key Responsibilities

  • Advances projects and implements established strategies and plans with guidance. Stays informed about relevant regulations.
  • Organizes and prepares registration submissions for medical device products in accordance with local regulatory standards.
  • With supervision, interprets and addresses correspondence from regulatory agencies.
  • Assesses changes in manufacturing and labeling 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 changes for regulatory agency review.
  • Represents Global Regulatory Affairs in research and development discussions, presenting agreed regulatory positions. May act as the primary regulatory representative for a designated product or project team.
Required Knowledge & Skills

  • Reviews and approves essential documents, seeking guidance when necessary. Evaluates technical reports for regulatory submission suitability.
  • Identifies deficiencies in registration documentation and collaborates with colleagues to resolve them.
  • Comprehends global regulations and ensures compliance to minimize development costs and timelines.
  • Prepares and maintains regulatory strategies under supervision.
  • Exhibits 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.
  • Understands scientific arguments, identifies necessary regulatory data, and aligns with regulatory management on issues.
  • Effectively communicates scientific data both orally and in writing in a coherent and persuasive manner.
  • Provides daily regulatory support to product development teams and commercial operations with guidance.
  • Participates in the formulation of regulatory strategies, reviewing submissions and regulatory commitments with management prior to execution.
  • Acts independently on routine matters, making informed decisions in line with regulatory management.
Qualifications & 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, with at least two years in Regulatory Affairs.
  • Ability to evaluate scientific arguments and apply analytical reasoning.
  • Capable of prioritizing tasks and managing multiple responsibilities with minimal supervision.
  • Strong interpersonal skills.
  • Effective oral and written communication abilities.
  • Demonstrated project management capabilities.
  • Exhibited 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.

  • Regulatory Affairs Operations Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Experis Full time

    Our client, a prominent player in the Healthcare sector, is seeking a Regulatory Affairs Operations Specialist II. In this role, you will be tasked with executing intricate global regulatory strategies, securing and upholding marketing authorizations for products, and conveying essential regulatory requirements to facilitate the licensing of...

  • 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...

  • Regulatory Affairs Operations Specialist II

    2 weeks ago

    Round Lake, Illinois, United States Experis Full time

    Position Overview:We are seeking a skilled Regulatory Affairs Operations Specialist II to support our healthcare initiatives. This role involves the execution of complex global regulatory strategies and the maintenance of marketing authorizations for various products.Key Responsibilities:Formulating and implementing intricate regulatory project...

  • Quality Assurance Specialist

    1 week ago

    Lake Forest, Illinois, United States Abbott Laboratories Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Abbott Laboratories. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and integrity of our products and processes.Key ResponsibilitiesImplement and maintain the effectiveness of the Quality System, ensuring compliance with...

  • Lead Tax Accounting Specialist

    2 weeks ago

    Lake Forest, Illinois, United States The LaSalle Group Full time

    We are seeking a meticulous and seasoned Lead Tax Accounting Specialist to oversee and direct our client's tax accounting functions. The successful candidate will possess a robust background in tax compliance, reporting, and strategic planning, emphasizing precision and adherence to regulatory standards. This position is vital in supporting the...

  • Manufacturing Automation Specialist

    2 weeks ago

    Lake Forest, Illinois, United States Lorenz Engineering, a division of The Salem Group Full time

    Manufacturing Automation SpecialistDirect Hire OpportunityPosition Overview:The Manufacturing Automation Specialist will play a crucial role in the design, development, and execution of automated systems and processes within the manufacturing sector. The successful candidate will have a solid background in PLC programming and integration, which will...

  • Records Management Specialist

    6 hours ago

    Lake Forest, Illinois, United States Rose International Full time

    Job SummaryRose International is seeking a highly skilled Records Management Analyst to join our team. As a key member of our organization, you will be responsible for managing and maintaining our records management system, ensuring compliance with regulatory requirements and company policies.Key ResponsibilitiesRecords Management: Develop and implement...

  • CAPA Process Analyst

    4 days ago

    Lake Forest, Illinois, United States GTT, LLC Full time

    Job SummaryWe are seeking a highly skilled CAPA Process Analyst to join our team at GTT, LLC. As a key member of our quality assurance team, you will be responsible for leading investigations and implementing corrective actions to ensure compliance with regulatory requirements.Key ResponsibilitiesInvestigation and Root Cause Analysis: Lead complex and...

  • Patient Access Coordinator

    5 days ago

    Lake Forest, Illinois, United States Northwestern Medicine Full time

    About the RoleThe Patient Access Specialist plays a vital role in ensuring seamless patient access to healthcare services at Northwestern Medicine. This position requires a strong understanding of healthcare operations and a commitment to delivering exceptional patient experiences.Key ResponsibilitiesReflect the mission, vision, and values of Northwestern...

  • Medical Office Coordinator

    5 days ago

    Lake Forest, Illinois, United States Northwestern Medicine Full time

    About the RoleThe Patient Access Specialist plays a vital role in ensuring seamless patient access to healthcare services at Northwestern Medicine. This position requires a strong understanding of healthcare operations and a commitment to delivering exceptional patient experiences.Key ResponsibilitiesReflect the mission, vision, and values of Northwestern...

  • Youth Support Services Specialist II

    1 week ago

    Park Forest, Illinois, United States AUNT MARTHAS HEALTH AND WELLNESS INC Full time

    Job OverviewAunt Martha's Health and Wellness Inc. is committed to enhancing the health and wellness of our communities, ensuring equitable access to care, and providing outstanding services driven by innovation. Our dedication to safety includes a requirement for all employees to receive COVID-19 vaccinations and provide proof upon joining our...

  • Youth Support Services Specialist II

    2 weeks ago

    Park Forest, Illinois, United States AUNT MARTHAS HEALTH AND WELLNESS INC Full time

    Job OverviewAunt Martha's Health and Wellness Inc. is committed to enhancing the health and welfare of our communities, ensuring equitable access to services, and providing outstanding care driven by innovation. As part of our dedication to safety, we require all employees to be vaccinated against COVID-19 and to provide appropriate documentation.POSITION...

  • Software Quality Assurance Specialist

    1 day ago

    Lake Forest, Illinois, United States Precise Solutions Full time

    Job DescriptionPrecise Solutions is seeking a highly skilled Quality Assurance Engineer to join our team in the development of Software as a Medical Device (SaMD) and Digital Health Software products.Key Responsibilities:Represent QA on cross-functional teams and execute Quality System requirements to ensure products are developed, tested, and released in...

  • Quality Assurance Specialist

    5 days ago

    Round Lake, Illinois, United States Takeda Pharmaceutical Company Ltd Full time

    About the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Takeda Pharmaceutical Company Ltd. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products.Key ResponsibilitiesResponsible for the receipt, release, and investigation of raw materials and bulk...

  • Quality Assurance Specialist for Medical Software

    1 week ago

    Lake Forest, Illinois, United States Precise Solutions Full time

    Job OverviewAt Precise Solutions, we are seeking exceptional professionals to join our organization and support our clients in the Life Sciences sector. We pride ourselves on being more than just a consulting firm; we offer competitive compensation packages that include attractive salaries, comprehensive benefits, health insurance, paid time off, and...

  • Clinical Nurse Specialist

    1 week ago

    Lake Forest, Illinois, United States Northwestern Memorial Healthcare Full time

    Job OverviewAt Northwestern Memorial Healthcare, we prioritize every patient interaction, fostering a positive environment that distinguishes us as a leader in the healthcare sector. Our commitment to a patient-centered approach is at the core of our mission. We offer a range of competitive benefits, including tuition reimbursement, loan forgiveness, 401(k)...

  • Electrical Infrastructure Supervisor

    5 days ago

    Lake Forest, Illinois, United States Northwestern Memorial Healthcare Full time

    Job SummaryWe are seeking an experienced Electrical Supervisor to join our team at Northwestern Memorial Healthcare. The successful candidate will be responsible for overseeing electrical work throughout our hospital facilities, ensuring compliance with regulatory codes and standards.Key ResponsibilitiesElectrical Work Oversight: Supervise and direct...

  • Electrical Supervisor

    5 days ago

    Lake Forest, Illinois, United States Northwestern Memorial Healthcare Full time

    Job SummaryWe are seeking an experienced Electrical Supervisor to join our team at Northwestern Memorial Healthcare. The successful candidate will be responsible for overseeing electrical work throughout our hospital facilities, ensuring compliance with regulatory codes and standards.Key ResponsibilitiesElectrical Work Oversight: Supervise and direct...

  • Laboratory Specimen Processing Specialist

    2 days ago

    Lake Forest, Illinois, United States GTT, LLC Full time

    Job SummaryWe are seeking a highly organized and detail-oriented Laboratory Specimen Processing Specialist to join our team at GTT, LLC. As a key member of our Specimen Processing Department, you will be responsible for ensuring the efficient and accurate processing of laboratory specimens.Key Responsibilities:Process and prepare laboratory specimens for...

  • GMP Compliance Auditor

    2 weeks ago

    Round Lake, Illinois, United States Ventura Solutions Inc. Full time

    We are excited to announce an opening for a GMP Compliance Auditor on a contractual basis. This position is pivotal in ensuring adherence to the company's policies, regulatory requirements, and international standards. The GMP Compliance Auditor will work collaboratively across various departments to enhance the auditing capabilities within Quality...