At the Ivoclar Group, we support dentists, dental technicians and dental hygienists both professionally in fulfilling their passion and purpose: to ensure that people have the best possible oral health care and quality of life, today and in the future.
We are inspired by the knowledge that together we are better.Do you want to work together with us to make people smile? Then come and join our global team as
Quality Assurance & Regulatory Affairs Manager m/f/x
Your Responsibilities:
You will drive continuous improvement of the Quality System by identifying priorities, optimizing Quality Assurance processes, and ensuring full compliance with regulatory requirements.
You will manage critical product quality processes such as shipment release decisions, labeling verification, creation of Safety Data Sheets, and handling of returns or product discontinuation.
You will act as the primary Quality & Regulatory liaison with global teams, industry bodies, and competent authorities, ensuring clear, timely, and accurate communication.
You will lead and develop Quality team members by providing training, fostering cross‑functional collaboration, and actively participating in audits and quality meetings to support business alignment and high performance.
You will serve as both, the Soseki (quality system owner) and Hinseki (final accountable authority), holding end-to-end responsibility for quality decisions, system integrity, and regulatory compliance.
Your Qualifications:
You will meet one of the legally required qualifications:
– Licensed Pharmacist, or
– Completion of a university‑level specialized course in chemistry or pharmaceutical sciences, or
– 5+ years of practical experience in manufacturing/marketing of medical devices, pharmaceuticals, or regenerative medicine products plus the Medical Device Responsible Officer qualification and 3 years of manufacturing experience in pharmaceuticals, cosmetics, or quasi-drugs.
Proficient English communication skills, both written and verbal
Excellent organizational, analytical, and communication skills, enabling confident decision‑making in a regulated environment
Let's achieve our goal together.
If you are looking for a job where you can contribute actively, develop personally and professionally and make a lasting difference then this is the right place for you.
As an international family business with a long-term perspective, we know that it is our roughly 3,600 employees that are the key to our success.
Let's achieve our goal together:
Making People Smile.
We are looking forward to receiving your online application.
職務レベル
スタッフレベル
雇用形態
正社員
職務タイプ
品質管理
業種
医療機器製造業
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