Job Description

Beckman Coulter Life Sciences\' mission is to empower those seeking answers to life\'s most important scientific and healthcare questions. With a legacy spanning 80+ years, we have long been a trusted partner to our customers, who are working to transform science and healthcare with the next groundbreaking discovery. As part of our team of more than 2,900 associates across 130 countries, you\'ll help drive our vision of accelerating answers-and our commitment to excellence. Beckman Coulter Life Sciences is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we\'re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives. The Staff Regulatory Affairs is part of the Miami Regulatory Affairs team and will support new product development, global registrations, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements. Responsibilities: Support complex regulatory strategies for global registration of IVD reagents and systems Lead EU, Canada, China and International registration activities Create high quality Technical documentation to comply with IVDR Create ROW high quality documentation such as technical dossier or STED and liaise with regional regulatory teams to ensure on time submission and clearance. Liaise and negotiate with regulatory agencies and notified bodies to ensure on time clearance of products in line with regulatory strategy and business commitment New Product Development: Actively contribute to development of project plans, deliverables, and timelines. Collaborate with cross functional teams for effective planning and on time execution of regulatory submissions. Product lifecycle management: Support product design changes, labeling updates, sustainment, and improvement activities from regulatory perspective. Assess regulatory impact, develop detailed action plan to drive regulatory compliance and ensure on time completion of identified actions. Apply Danaher Business System (DBS) tools to drive compliant and effective processes improve capability to support growth. Assure that there are no significant interruptions to the business due to regulatory or compliance issues. Qualifications - Education and Experience A Bachelor\'s degree in areas of life sciences or engineering field with a minimum of 5 years\' experience in a regulated medical device/diagnostic industry (less years required with advanced degree). Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Experience in supporting filing of pre-market regulatory submissions domestically (Q-Subs, 510ks) and internationally (IVDR China ROW Global Registrations). Knowledge of domestic and international quality systems and other standards such as FDA QSR, IVDD/IVDR, INVIMA, ANMAT, ANVISA, COFEPRIS, ISO 13485, ISO 9001 and other applicable standards and regulations. Knowledge of design control process requirements and requirements for technical documentation for diagnostics or medical devices. Experience with Software as a Medical Device (SAMD) and Software as an accessory to a device highly desirable. Fluency in English Qualifications - Personal Attributes : Critical thinker able to address complex situations and issues. Acts decisively, holds position and challenges others appropriately. Manages changing conditions, processes, and approaches leads organizations through change effectively. Ability to adopt a systemic view of process improvement and to advise process improvement teams to reach goals. Organized and thorough with a high level of initiative, self-motivation and energy. Quick adaptability to embrace company culture and flexibility to manage multiple projects at the same time. Ability to participate in meetings outside of regular business hours to support global business. When you join us, you\'ll also be joining Danaher\'s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you\'ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes. If you\'ve ever wondered what\'s within you, there\'s no better time to find out.

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