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Regulatory Affairs Manager Consumable Devices

Company name
ICU Medical

Lake Forest, IL

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Description FLSA Status: Exempt Position Summary:\u00a0 Develop and execute Global Regulatory Strategies and Plans to assure that new Infusion Systems products and changes to existing products are developed in line with the global registration requirements of targeted countries. Develop high quality US and global regulatory submissions that continue to build credibility with regulatory authorities. Obtain expedient registration for assigned products. Maintain registrations of existing products in compliance with applicable regulations Essential Duties & Responsibilities: \u2022 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. \u2022 Acts as Global Regulatory Affairs Lead on the cross functional teams developing and executing regulatory strategies, communicating regulatory requirements and ensuring they are incorporated into program deliverables\u00a0 \u2022 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 software driven medication delivery systems. \u2022 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. \u2022 Work with region and country RA counterparts to evaluate changes, and promotional materials for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. \u2022 Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs. \u2022 Work on special projects as they arise. Knowledge, Skills & Qualifications: \u2022 Proven strong record of preparing 510K submissions and obtaining clearances in their name. \u2022 Advanced ability to critically assess scientific arguments. \u2022 Excellent oral and written communication skills. \u2022 Excellent interpersonal skills. \u2022 Well-developed negotiating skills. Strong understanding of business needs. Education and Experience:\u00a0 \u2022 Bachelor\u2019s Degree is required: Pharmacy, Biology, Chemistry, Pharmacology, Engineering or related subject \u2022 A degree or experience in Engineering, Regulatory affairs or a related field that will assist with providing guidance to technical teams, technical writing, and in problem solving technical issues as they relate to product development, manufacture and global registrations. \u2022 Regulatory Affairs Certification preferred. \u2022 Advanced experience with assembling global dossiers. \u2022 Seven to ten years of medical device industry experience with a minimum of four years\u2019 in regulatory affairs with direct experience authoring 510(k) and\/or CE technical files. \u2022 Well-developed experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency regulations and applicable guidance documents. Minimum Qualifications: \u2022 Must be at least 18 years of age \u2022 Must pass pre-employment drug screen and background check Travel Requirements:\u00a0 \u2022 Typically requires travel less than 5% of the time Physical Requirements and Work Environment:\u00a0 \u2022 This job operates in a professional office environment and routinely uses standard office equipment. We are an Equal Employment Opportunity Employer, Female\/Minority\/Veterans\/Disabled\/Sexual Orientation\/Gender Identity. ICU Medical, Inc. encourages individuals with disabilities to apply for positions of interest. If you need accommodations to complete the application process, please contact Human Resources at 949-366-3578.\u00a0

Company info

ICU Medical

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