Associate II, Regulatory Affairs

ICU Medical • San Diego, CA

13h

About The Position

Position Summary Provide regulatory support and expertise associated with US and global submission requirements, including analysis of the requirements and tracking of deliverables. With oversight, supports execution of global regulatory strategies and assists in creation and maintenance of global registration dossiers. Assures full regulatory compliance of all documentation for submissions and change management to enable product approval and issuance of EC certificates, FDA or other international certificates/permits/approvals. Ensure that key strategic new products are developed in line with the global registration requirements. Essential Duties & Responsibilities Drives projects forward and executes agreed upon strategies and plans with oversight. Maintains awareness of applicable regulations. Plans and organizes registration packages for device products. Prepares registration packages in line with regional regulatory requirements and guidelines. With oversight, understand and respond to regulatory agencies or notified body correspondences. Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. Review and approve critical documents, seeking guidance when necessary. Review technical reports and determine acceptability for regulatory submission. Identify registration documentation deficiencies and work with colleagues to accomplish resolution. Understand global regulations and assure regulatory compliance, minimizing development costs and cycles. 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. Missed registration deadlines or inaccurate registration packages can delay regulatory approvals, which can result in missed sales or regulatory action letters Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions. May serve as a lead regulatory representative to an assigned product or project team. Reviews regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution. Work on special projects as assigned

Requirements

• Proven strong understanding of FDA, EU and worldwide submission requirements.
• Proven strong record of preparing regulatory submissions and obtaining approvals.
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
• Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.
• Prepare and maintain regulatory strategy with supervision.
• Advanced experience with assembling global dossiers
• Two to four years of medical device industry experience with regulatory affairs with direct FDA and global submission experience and authoring CE technical documentation.
• Strong understanding of 21 CFR 820 and ISO 13485:2016 requirements.
• Well-developed experience working directly with regulatory agencies.
• Sound knowledge of applicable portions of agency regulations and applicable guidance documents.
• Advanced ability to critically assess scientific arguments.
• Excellent oral and written communication skills.
• Strong problem-solving skills
• Excellent interpersonal skills.
• Well-developed negotiating skills.
• Strong understanding of business needs.
• Bachelor’s Degree required, preferably in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
• A minimum of two years of experience in Medical Products Industry in Regulatory Affairs.
• Able to assess scientific arguments and apply analytical and logical reasonings.
• Ability to effectively prioritize workload and multitask with minimal supervision.
• Good interpersonal skills.
• Good oral and written communications skills.
• Demonstrated project management skills.
• Demonstrated critical thinking, contingency planning and negotiating skills.
• Understanding regulatory and business needs with ability to engage cross functional team members.
• 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

• Drives projects forward and executes agreed upon strategies and plans with oversight.
• Maintains awareness of applicable regulations.
• Plans and organizes registration packages for device products.
• Prepares registration packages in line with regional regulatory requirements and guidelines.
• With oversight, understand and respond to regulatory agencies or notified body correspondences.
• Work with region and country RA counterparts to evaluate changes for regulatory impact and to ensure compliance with applicable regulations.
• Accurately describes these changes for ease of regulatory agency review.
• Review and approve critical documents, seeking guidance when necessary.
• Review technical reports and determine acceptability for regulatory submission.
• Identify registration documentation deficiencies and work with colleagues to accomplish resolution.
• Understand global regulations and assure regulatory compliance, minimizing development costs and cycles.
• 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.
• Represents Global Regulatory Affairs at research and development meetings and presents agreed upon regulatory positions.
• May serve as a lead regulatory representative to an assigned product or project team.
• Reviews regulatory commitments, strategy decisions, meeting strategies with regulatory authorities and changes to resource allocations with manager prior to execution.
• Work on special projects as assigned

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
• Additional information on health and welfare benefit offerings can be found at https://www.icumed.com/about-us/careers/investing-in-your-future/

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1,001-5,000 employees