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Senior/ Quality Regulatory Compliance Specialist
3 months ago
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Senior/ Quality Regulatory Compliance Specialist is responsible for overseeing, driving, and maintaining the registration process to get import license as required by organization strategy and policy. Support and align the applicable QMS within organization by acting as Organization’s Document Control Center.
Day to day responsibilities will include:
- Do prepare, register, and gather documents related to registration process to get both new and renew import licenses e.g. Certificate of Free Sale/ Certificate of Goods/ Free Sale Certificate, ISO/ any other applicable standard certificate, product catalogue/ brochure, Instruction for use/ Notice, and declaration letter (if needed).
- Do support any QRC related special projects that assigned by company policy as well as by the change of Thai FDA regulation and requirement.
- Incorporate with QRC manager to oversee the changes and/ or new legislations, requirements, applicable standard and/ or requirement that lead to impact to registration process and Quality Management System.
- Do gather, file, and maintain all data/ information regarding FSCA/ AE/ DD/ Customer Complaint and any other related QRC issues.
- Act as Document Control Center to handling all quality and regulatory documents related to applicable standard for Quality Management System.
Who you are:
At Getinge, we are looking for passionate individuals, who are agile, resilient, take responsibility for their development and focus on achieving excellence. They never compromise on quality and always act responsibly remembering that our customers always come first. They enjoy collaboration and working in diverse and international teams, and embrace the future. If you love change, we can make sure that you stay that way
Your experience includes:
- Bachelor’s degree in science background or related field.
- 3-5 years of experience in Medical Device products registration, Pharmaceutical or related field.
- Knowledge of registration process and/ or DCC for any applicable QMS is a must.
- Good command in English & Thai both written and spoken.
- Good computer literacy (MS Office: Word, Excel, Access, and Power Point).
- Good coordinator, relationship, and communication skill with other departments
- Good interpersonal skills and service orientation.
- Ability to do multi-tasks & manage priorities under pressure.
Our Benefits
We offer a competitive compensation and benefits package, including wellness and training programs, to ensure we support your well-being and goals.
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
