Regulatory Affairs Specialist, Medical Device

Job description

JOB DESCRIPTION: ABOUT ABBOTT Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. WORKING AT ABBOTT At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to: Career development with an international company where you can grow the career you dream of. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. Main Purpose of Job: Responsible for activities which lead to and maintain regulatory approval to market devices. Works with various stakeholders such as labeling / global team for launch readiness. Develops and implements strategies for earliest possible approvals. Ensures timely preparation of submissions. Builds rapport with regulatory agencies. Anticipates regulatory environment change and manages the regulatory intelligence for new policy, regulation etc. as required. Key Responsibilities: Manage the regulatory approval or registration of medical devices and license maintenance. Develop registration strategies, prioritizing assignments, implementing regulatory plan, and coordinating multiple projects and activities in accordance with strategic company objectives, submission plan and targets. Research and monitors regulatory requirements for assigned geographies / competent authority Monitor requirements of related medical device laws & regulations Cultivation of professional working relationships with competent authorities and local medical device industry association Review and approval of A&P materials to ensure compliance with local regulations. Ensure proper documentation and record management of submission, approvals, certificates as required. Handle/supports regulatory related processes or projects, e.g. labeling project, PRA process Qualifications / Education Required: Diploma, Advanced/Higher/Graduate Diploma, Bachelor’s degree or equivalent, preferrably in pharmacy, health sciences or related science background Skills and Experience: Regulatory Affairs Specialist: 2 years experience in Medical Device Regulatory Affairs preferred. Senior Regulatory Affairs Specialist : Minimum 3 years Regulatory Affairs experience (preferablly in Medical Device industry) Proficient in Microsoft Office applications especially excel files. Effective interpersonal, communication and analytical skills Proficiency in written and spoken English and Local language. Independent. Highly result oriented; ability to deliver and overcome obstacles. The base pay for this position is N/A In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: MD Medical Devices LOCATION: Vietnam > Hanoi : Handi Resco Tower ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)