Manager, Regulatory Affairs – Electromechanical Devices (hybrid)

ICU Medical • Lake Forest, CA

22h • Hybrid

About The Position

The Manager, Regulatory Affairs is a working Manager who assists in development and execution of Global Regulatory Strategies and Plans to assure that new products and changes to existing products are developed in line with the global registration requirements of targeted countries in support of the electromechanical devices in the Infusion Systems business. Develop high quality US, EU MDR and global regulatory submissions that continue to build credibility with regulatory authorities/notified bodies. Obtain expedient registration for assigned products. Maintain registrations of existing products in compliance with applicable regulations.

Requirements

• Expertise with creating 510(k) submissions for electromechanical devices with embedded software to FDA CDRH in the past 3 years, is required.
• 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.

Nice To Haves

• RAC Certification preferred.

Responsibilities

• 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.
• Assesses scientific data provided for registration purposes to ensure it meets regulatory requirements.
• Review and approve critical documents, seeking guidance when necessary.
• Review technical reports and determine acceptability for regulatory submission.
• Identify registration documentation deficiencies, work with colleagues to accomplish resolution, and execute plans to mitigate the risk to approval.
• Interpret global regulations and assure regulatory compliance, minimizing development costs and cycles.
• Define and negotiate regulatory strategy with management alignment.
• 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.
• Follows scientific arguments, identifies regulatory scientific data needs and solves regulatory issues with alignment with regulatory management.
• Presents scientific data effectively orally and in writing in a logical and persuasive manner.
• Summarizes complex technical data into narratives that facilitate review by regulatory authorities.
• Provides daily regulatory support to direct reports in RA, for new product development teams and for maintenance of commercial products.
• Includes providing regulatory management oversight and direction to team members for strategy development, submission review, ensuring regulatory commitments are met and changes to resource allocations are aligned with direct manager prior to execution.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees