Director, Quality and Regulatory Affairs, Diagnostics SEA
2 weeks ago
Specific duties include but are not limited to:
Lead and manage a team of regulatory and quality professionals, fostering a culture of excellence, collaboration, and continuous improvement including: creating regulatory strategies, preparation of regulatory submissions, interactions with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on global agencies and submissions as required. Mentor and coach team on complex regulatory and quality business initiatives. Direct, coordinate and manage field action processes including tracking and verification of effectiveness and collaborating with regional teams. Actively participate in the development and execution of strategic initiatives, and operational leadership meetings to support the Quality Assurance & Regulatory Affairs team and perform other duties as assigned including special projects. Collaborate cross-functionally to drive continuous improvement in customer satisfaction through design assurance, supplier quality improvement, manufacturing process controls, and service activities. Translate strategy/plan into goals by leading with DBS and managing the team’s sustained delivery on performance metrics.The essential requirements of the job include:
Bachelor’s degree in Life Sciences or related fields with 14+ years of experience, OR Master’s/Doctoral degree with 12+ years of experience; AND at least 4 years of managing people. Experience leading regulatory submissions and interactions with regulatory authorities in different countries with an in-depth knowledge of global regulatory requirements, standards, and guidelines. Knowledge of ISO 9001, ISO 13485, and US FDA 21 CFR Part 820 Quality Systems regulations. Intermediate proficiency in English and Microsoft Office applications. Strong written and communication skills; comfortable working in a dynamic multi-functional matrix organization.It would be a plus if you also possess previous experience in:
Multilingual proficiencies in Thai, Vietnamese, and/or Malay. Technical experience within the in vitro diagnostic or medical device industries.At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what’s next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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.
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