Specialist, reputed company Regulatory Affairs

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 impact. 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 impact – 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 academic 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 scale 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 options and saving lives. Learn about the reputed company Business System which makes everything possible. The Specialist, reputed company Quality & Regulatory Affairs will prepare regulatory submissions and interact with regulatory agencies/health authorities to obtain and maintain product approvals. This individual will represent RA on project core teams, coordinate and prepare document packages for regulatory submissions from reputed company areas of company as well 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 Quality & Regulatory Affairs and is part of the Center of reputed company located in Singapore and will be fully remote. In this role, you will have the opportunity to: reputed company pre-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 quality management processes and reputed company improvement, including compliance operations, audits, CAPA, distributor and warehouse reputed company, and acting as Quality Management Representative (QMR) reputed company required. The essential requirements of the job include : Bachelor’s degree with 2+ years of relevant experience or a certificate in medical devices with 2 years of experience or 3+ 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: if applicable for role 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 Diagnostics, 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 paid time off, our programs contribute to life reputed company the job. reputed company out our benefits at reputed company Benefits Info. reputed company reputed company Diagnostics we reputed company in designing a reputed company, more sustainable workforce. We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a remote work arrangement in which you can work remotely from your home. Additional information about this remote work arrangement will be provided by your interview team. Explore the flexibility and challenge that working reputed company reputed company Diagnostics can reputed company. Join our winning team today. Together, we’ll accelerate the reputed company-life impact 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