Manager, Regulatory Affairs – Electromechanical Devices

ICU Medical

Manager in Regulatory Affairs overseeing global registration strategies for electromechanical devices. Responsible for submissions and compliance in the Infusion Systems business.

Posted 4/25/2026full-timeLake Forest • Illinois • 🇺🇸 United StatesSeniorLead💰 $112,500 - $161,250 per yearWebsite

About the role

Key responsibilities & impact

Develops regulatory strategies for development projects, design changes and manufacturing improvements, and analyzes risk vs. benefit in regulatory strategies to ensure successful review by global regulatory authorities.
Directs submission related activities by leading the team and motivating the staff to successfully execute regulatory strategies. Makes independent judgments and decisions based on regulations and professional experience. Ensures alignment with Regulatory Management as appropriate.
Acts as Global Regulatory Lead on the cross functional teams developing and executing regulatory strategies, communicating regulatory requirements, and ensuring these requirements are incorporated into program deliverables.
Manages the preparation of global registration packages and responses to requests for additional information. Negotiates submission data requirements and deliverable dates with internal technical teams. Author with team members, regulatory submissions for the Infusion Systems infusion pump product portfolio.
Acts as a point person for regulatory agency interactions (either written or oral) including preparation of briefing packages and strategy for meetings, inspections, advisory committee meetings, and responses to agency letters pertaining to the assigned products.
Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes changes and present scientific rationale for ease of regulatory agency review.
Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs.

Requirements

What you’ll need

Eight years of medical device industry experience with a minimum of five years in regulatory affairs with direct experience and authoring 510(k) and/or CE technical files.
RAC Certification preferred.
Bachelor’s Degree required in pharmacy, biology, chemistry, pharmacology, engineering or related subject. 2-4 years of managerial experience.
Direct experience in working with regulatory agencies. Sound knowledge of applicable portions of agency regulations and applicable guidance documents.
2 – 4 years of direct experience with electromechanical devices with embedded software, is required.
Ability to lead scientific arguments and apply analytical and logical reasonings.
Ability to effectively prioritize workload for self and others.
Proven experience of preparing 510(k) submissions and obtaining clearances in their name.
Good interpersonal skills and strong 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.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory strategiesregulatory submissions510(k) submissionsCE technical fileselectromechanical devicesembedded softwarerisk analysisregulatory complianceproject managementscientific rationale

Soft Skills

leadershipinterpersonal skillsoral communicationwritten communicationanalytical reasoninglogical reasoningprioritizationcritical thinkingnegotiating skillscontingency planning

Certifications

RAC Certification