Regulatory Affairs Associate III

  • Location
    Pleasanton , California
  • Category
    Medical & Science - Regulatory
  • Job type

Adecco Medical and Science has a current job opportunity for Regulator Affairs Associate III
in Pleasanton, CA. for a 3-month Contract opportunity

JOB REQUIREMENTS:This person Essential Duties and Responsibilities include the following (other duties may be assigned):

• Assists in the development and deployment of the regulatory program that ensures aggressive product approval, adoption within the international standard ISO13485; 21 CFR 803, 806, and 820; the current Canadian Medical Device Regulations (SOR 980282); Medical Device Directive 93/42/EEC (and all applicable amendments); MHLW Ordinance No 169 and other applicable regulations and guidelines in accordance with corporate objectives
To be considered for this position contact James Ratliff at (925) 349-0303 or at

BS or BA degree, 1-3 years of experience in regulatory affairs.

• Experience in a company start-up environment, preferably in medical devices or combination products.

• Knowledge of FDA, CA-FDB, and ISO regulations/standards, including ISO 10993 (requirements for biocompatibility).

• RAC certification in US, EU, and/or CAN is a plus.

• Ability to focus on and achieve scheduled milestones, including contingency planning.

• Strong team-working and communication skills. A drive to get the job done in the face of obstacles and time constraints, and a willingness to jump in wherever needed.

• Competent using office software including MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.

  • Apply with Adecco

Reference number US_EN_2_108218_319468