Location: Bothell WA
Duration: 6 Months+
Experience: More than 5 years professional experience. Education: Bachelor's Degree or equivalent work experience in FDA regulated industry (Medical Device, Cosmetics, Pharma).
Responsible for identifying regulatory requirements and standards for new product development, product updates, and new country launches. Develops protocols for verifying compliance to the standards and oversee testing at contract labs to collect evidence of compliance to the regulatory and standards requirements. Additionally, review product complaints from international consumers and assess for necessary containment actions and any regulatory reporting requirements.
Familiarity with the following Regulations and Standards desired:
Regulations: 21CFR820, ISO 13485, EU 1223/2009, EU MDD & MDR.
Standards: ISO 10993, USP 661, REACH, RoHS, EN 55014, EN 62233, FCC Part 15, FCC Part 18, UL 60950, UL 1642, UL 1431, EN 60950, EN 62133, IEC 60335, ISO 20127