Position Summary 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. Essential Duties & 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. Knowledge, Skills & Qualifications * 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. Education and Experience * Bachelor's Degree required in pharmacy, biology, chemistry, pharmacology, engineering or related subject. * Master's Degree or P.H.D preferred * RAC Certification preferred. * Eight plus years of medical device industry experience with a minimum of five years in regulatory affairs with direct experience with 510(k) and/or CE technical files. * Direct experience in working with regulatory agencies. Sound knowledge of applicable portions of agency regulations and applicable guidance documents. * Ability to lead scientific arguments and apply analytical and logical reasonings. * Ability to effectively prioritize workload for self and others * Experience with 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. Travel Requirements Typically requires travel 5-20% of the time Physical Requirements and Work Environment * This is largely a sedentary role. * This job operates in a professional office environment and routinely uses standard office equipment. This role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York. 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.
