Compliance Engineer, RAQA
Stryker
- Lund, Skåne
- Permanent
- Heltid
- Working knowledge with IEC standards for medical devices such as: IEC 60601 series / 62133-2 / IEC 62366-1 / ISO 14971 / ISO 13485
- Working knowledge with international regulations like: 21 CFR 820 / EU-MDR, RED / Low Voltage Directive 2014/35/EU (LVD) / SOR 98-282 / Australian Therapeutic Goods Act (TGA) / MHLW Ministerial Ordinance No. 169
- Working knowledge of regulations and best practices in the following areas: RoHS, REACH, WEEE, Battery, Packaging, and Proposition 65