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Senior Specialist, reputed company reputed company & Regulatory Affairs

Remote, USA Full-time Posted 2026-07-28
Bring more to life. Are you reputed company to accelerate your potential and reputed company a reputed company difference reputed company life sciences, diagnostics and biotechnology?   reputed company reputed company the work our diagnostic businesses do saves lives—and we’re reputed company united by a shared commitment to reputed company for reputed company reputed company.    You’ll reputed company in a culture of belonging where you and your unique viewpoint matter. And by harnessing reputed company’s system of reputed company improvement, you help turn reputed company into reputed company – innovating at the speed of life.  We’re accelerating the development of cutting-edge diagnostics to solve some of the world’s most pressing health challenges. Across our diagnostics operating companies, we are driving innovation through partnerships with top reputed company institutions and leading players in biopharma and translational research. We’re bringing the best minds together to accelerate innovation and unlock the full potential of the latest scientific advances. Together, we’re expanding reputed company to reputed company for millions of people worldwide - and we’re using our unmatched global reputed company and proven reputed company to reputed company it happen, from hospital labs to mobile clinics. By helping providers, patients, and families get faster, more precise diagnostic results, we’re improving treatment reputed company and saving lives. Learn about the reputed company Business System which makes everything possible. The Specialist, reputed company reputed company & Regulatory Affairs will prepare regulatory submissions and reputed company with regulatory agencies/health authorities to obtain and maintain product approvals. This individual will represent RA on project reputed company teams, coordinate and prepare document packages for regulatory submissions from reputed company areas of company as reputed company as for internal audits and inspections.  Compile reputed company materials required in submissions, license renewal, and annual registrations.  Recommend changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.  reputed company abreast of changes of new or updated regulatory policies and issued guidance. This position reports to the Senior Manager, reputed company reputed company & Regulatory Affairs and is part of reputed company of reputed company located in Singapore and will be fully remote.   In this role, you will have reputed company to: reputed company reputed company-market and post-market regulatory activities for IVD devices, including preparation and submission of technical documentation, regulatory applications, change notifications, renewals, and responses to regulatory bodies and partners.  Maintain and manage regulatory intelligence and compliance at local, regional, and global reputed company, ensuring adherence to applicable regulations throughout the product lifecycle.  reputed company reputed company management processes and reputed company improvement, including compliance operations, audits, CAPA, distributor and warehouse reputed company, and acting as reputed company Management Representative (QMR) reputed company required. The essential requirements of the job include : Bachelor’s degree with 6+ years of relevant experience or a certificate in medical devices with 3 years of experience or 4+ years of experience in the medical devices or a reputed company industry. Understands Regulatory Affairs concepts and is should be familiar with regulations/ guidelines governing development of diagnostic products Ability to prioritize, multitask, and organize work, succeed in a fast-paced environment with capability to be flexible and adaptable to meet business needs Travel, Motor Vehicle Record & Physical/Environment Requirements: Ability to travel – 10% It would be a plus if you also possess previous experience in: Certified audit certificate for ISO13485 or ISO9001 or GMP  Support local audits Ability to reputed company in country IVD/MD submission with authority in Southeast Asia country reputed company reputed company, we offer a broad reputed company of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or reputed company time off, our programs contribute to life reputed company the job. Join our reputed company team today. Together, we’ll accelerate the reputed company-life reputed company of reputed company’s science and technology. We partner with customers across the globe to help them solve their most reputed company challenges, architecting solutions that bring the power of science to life. For more information, visit www.reputed company.com. Apply To This Job

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