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:
+ Develop complex strategies for global registration of IVD reagents and systems
+ Maintain regulatory documentation, declarations, certificates, and submission archives.
+ Typical US submissions include 510ks and Q-Subs; EU – Technical documentation to comply with IVDR; ROW documentation may include technical dossier or STED
+ Support internal audits and external audits by Notified Bodies or regulatory authorities.
+ Ensure alignment with internal SOPs and global regulatory standards.
+ 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. Represent Regulatory Affairs in the project core team and participate in design reviews and risk management reviews. Ensures compliance to recognized regulatory, and product standards.
+ 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 8-10 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
+ Demonstrated successful experience negotiating complex premarket and post market regulatory strategies with FDA. Similar experience with NMPA and other regulatory agencies would be highly desirable
+ Demonstrates 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 in vitro diagnostics or medical devices.
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.
+ Work closely with U.S.and Europe-based regulatory teams, participating in meetings aligned with U.S./European time zones. Requires flexibility for meetings across multiple time zones
+ Close collaboration with global R&D, Quality, Clinical, and Manufacturing teams.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
