Position Summary: 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: • 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. • 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 • 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. • 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, and promotional materials for regulatory impact and to ensure compliance with applicable regulations. Accurately describes these changes for ease of regulatory agency review. • Maintains awareness of global regulatory legislation and assesses its impact on business and product development programs. • Work on special projects as they arise.
Knowledge, Skills & Qualifications: • Proven strong record of preparing 510K submissions and obtaining clearances in their name. • Advanced ability to critically assess scientific arguments. • Excellent oral and written communication skills. • Excellent interpersonal skills. • Well-developed negotiating skills. Strong understanding of business needs.
Education and Experience: • Bachelor’s Degree is required: Pharmacy, Biology, Chemistry, Pharmacology, Engineering or related subject • 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. • Regulatory Affairs Certification preferred. • Advanced experience with assembling global dossiers. • Seven to ten years of medical device industry experience with a minimum of four years’ in regulatory affairs with direct experience authoring 510(k) and/or CE technical files. • Well-developed experience working directly with regulatory agencies. Sound knowledge of applicable portions of agency regulations and applicable guidance documents.
Minimum Qualifications: • Must be at least 18 years of age • Must pass pre-employment drug screen and background check
Travel Requirements: • Typically requires travel less than 5% of the time
Physical Requirements and Work Environment: • 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.
ICU Medical connects patients and caregivers through safe, life saving, life enhancing medical devices.
We are one of the world’s leading pure-play infusion therapy companies, with global operations and a wide-ranging product portfolio that includes IV solutions, IV smart pumps, dedicated and non-dedicated IV sets and needlefree connectors, along with pain management and safety software technol...ogy designed to help meet clinical, safety and workflow goals. In addition, we manufacture automated pharmacy IV compounding systems with workflow technology, closed systems transfer devices for hazardous IV drugs, and cardiac monitoring systems to optimize patient fluid levels.
With the acquisition of the Hospira Infusion Systems business from Pfizer in February 2017, we are building an entirely new organization—one that is wholly focused on infusion therapy and committed to delivering quality, innovation, and value to our customers worldwide.