Randstad Quality Regulatory Engineer in Bothell, Washington

Quality Regulatory Engineer

job details:

  • location:Bothell, WA

  • salary:$40 - $48 per hour

  • date posted:Thursday, March 1, 2018

  • job type:Contract

  • industry:Health Care and Social Assistance

  • reference:600868

job description

Quality Regulatory Engineer

job summary:

We are looking for a Quality Regulatory Engineer in Bothell, WA

Experience: More than 5 years professional experience. Education: Bachelor's Degree or equivalent work experience in FDA regulated industry (Medical Device, Cosmetics, Pharma).

Description : 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.

location: Bothell, Washington

job type: Contract

salary: $40 - 48 per hour

work hours: 8 to 5

education: Bachelors

responsibilities:

Description :

  • 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.

qualifications:

Experience: More than 5 years professional experience.

Education: Bachelor's Degree or equivalent work experience in FDA regulated industry (Medical Device, Cosmetics, Pharma).

skills: 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

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.