Senior Associate, Regulatory Affairs

Regulatory Jobs; Lake Forest (IL); On-site; USD 98,000 - 140,000; Full time

Benefits offered by this job

401(k) match

Tuition reimbursement

Health, dental, vision insurance

Job summary

ICU Medical is seeking an experienced Regulatory Affairs professional to support global and US registrations for device electro mechanical products. The role involves analyzing regulatory requirements, creating global strategies, and ensuring compliant submissions and change management.

You will coordinate with cross-functional teams and regulatory agencies to facilitate timely approvals. Ideal candidates have extensive regulatory experience, strong analytical and communication skills, and a

Qualifications

• Must be at least 18 years of age.
• Bachelor’s degree from an accredited college in pharmacy, biology, chemistry, pharmacology, engineering or related field.
• Master’s degree or PhD preferred.
• RAC certification preferred.
• Seven plus years of experience in Medical Products Industry with a minimum of 3 years in Regulatory Affairs.

Responsibilities

• Provide regulatory advice and support to assigned products/teams, identifying registration needs and strategies.
• Plan and organize registration packages for device products per local requirements and guidelines.
• Serve as liaison with regulatory agencies and prepare agency meeting packages and strategies.
• Evaluate manufacturing and labeling changes for regulatory impact and describe changes for agency review.
• Collaborate with regional RA counterparts on regulatory impact and compliance.
• Represent Global Regulatory Affairs at R&D meetings and lead regulatory positions for products or projects.

Skills

Regulatory expertise

Global regulatory experience

US regulatory knowledge

Regulatory strategy

Documentation review

Project management

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree in pharmacy/chemistry/related field

Master’s degree preferred

RAC certification preferred

Job description

Position Summary

Provides regulatory support and expertise associated with global and US registration of device electro mechanicalproducts, including in-depth analysis of the requirements and tracking of deliverables. Withoversight, supports creation of global regulatory strategies and assists in execution includingcreation and maintenance of global registration dossiers. Assures full regulatory compliance of alldocumentationfor submissions and change management.

Essential Duties & Responsibilities

• Provides regulatory advice and support to assigned products/teams.Identifies andcommunicates registration needs and strategies.Maintains awareness of applicableregulations.
• Plans and organizes registration packages for device products.Prepares registration packagesinline with local regulatory requirementsand guidelines.
• Withoversight,servesasaliaisonwithregulatoryagenciespertainingtoassignedproducts.Assistsinthepreparationofagencymeetingpackagesandstrategiesforagencymeetings.
• Evaluates manufacturing and labeling changes for regulatory impact.Accurately describesthesechanges for ease of regulatoryagency review.
• Work with region and country RA counterparts to evaluate changes for regulatory impact andto ensure compliance with applicable regulations.Accurately describes these changes for easeofregulatory agency review.
• Represents Global Regulatory Affairs at research and development meetings and presentsagreed upon regulatory positions. May serve as a lead regulatory representative to an assignedproductor project team.

Knowledge & Skills

• Review and approve critical documents, seeking guidance when necessary.Review technicalreportsanddetermineacceptabilityforregulatory submission.
• Identify registration documentation deficiencies and work with colleagues to accomplishresolution.
• Interpret global regulations and assure regulatory compliance, minimizing development costsand cycles.
• Defineandnegotiateregulatorystrategywithsupervision.
• Exercisegoodjudgmentwithinpolicyandregulations.
• Responsible for tracking and completion of assigned registration activities.
• Accountable foraccuracy of work and meeting multiple, simultaneous deadlines.Missed registrationdeadlines or inaccurate registration packages can delay regulatory approvals, which can resultinmissed sales orregulatory actionletter.
• Follows scientific arguments, identifies regulatory scientific data needs and solves regulatoryissueswith alignment ofregulatorymanagement.
• Presentsscientificdataeffectivelyorallyandinwritinginalogical andpersuasivemanner.
• Providesdailyregulatorysupporttonewproductdevelopmentteamsandcommercialsupportwithguidance.
• Participates in preparing regulatory strategies.Reviews submissions, regulatorycommitments, strategy decisions, and changes to resource allocations with manager prior toexecution.
• Actsindependentlyonallroutineissues,makesjudgmentandexecutes.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age
• High School Diploma required
• Bachelor’s degree from an accredited collegein pharmacy, biology, chemistry, pharmacology, engineering orrelatedsubjector university is required
• Master’sDegreeorP.H.Dpreferred
• RACCertificationpreferred
• Seven plus years of experience in Medical Products Industry with a minimum of 3 years ofexperiencein Regulatory Affairs.
• Abletoleadscientificargumentsandapplyanalyticalandlogicalreasonings.
• Abilitytoeffectivelyprioritizeworkloadandmultitaskwithminimalsupervision.
• Goodinterpersonalskills.
• Goodoralandwrittencommunicationsskills.
• Demonstratedprojectmanagementskills.
• Demonstratedcriticalthinking,contingencyplanningandnegotiatingskills.
• Understanding of regulatory and business needs with ability to establish direction andinfluencecross 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

Salary Range - $97,500 - $139,750

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/.