Regulatory Affairs Expert
2 tygodni temu
Company Overview
">Solventum is a pioneering company at the intersection of health, material, and data science.
Job Description">We are seeking a Senior Regulatory Affairs Specialist to join our team in Wrocław. This role will be responsible for leading regulatory affairs on cross-functional teams and owning product line submissions and registrations across the globe for the dental solutions business.
The successful candidate will have direct experience authoring submissions/technical documentation for US, Canada, EU, and supporting EMEA, APAC, and LATAM regions.
This role requires strong technical writing and verbal skills in English, as well as expertise in design control verification and validation activities and clinical requirements for medical devices.
Required Skills and Qualifications">- Bachelor's Degree or higher from an accredited university in a scientific discipline such as Biology, Chemistry, Biomedical Engineering, or Physics.
- 7-10 years in regulatory affairs in the medical device industry.
- Direct experience authoring regulatory strategies and regulatory change assessments.
- Expertise in labeling (including marketing claims) that meet global regulatory requirements.
Apart from the mentioned qualifications, experience working in the dental device field or with dental products would be beneficial.
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