Regulatory Specialist II (Contract, San Jose, CA)

Description:

Roche is looking for a Regulatory Specialist II in San Jose, CA. It is a 12-36 months contract on W2.

Please email your Resume attached as a Word Doc along with your desired Hourly Rate, your current location, visa status and date you are available to start a new position. Please make certain your resume clearly details your experience with the skills required for this role.

Also please provide a brief writeup about why you are a match for the position that can be passed along to the manager. If you have worked at Roche or Genentech in the past please provide your previous managers names, so they too can be passed along to the hiring manager.

Duties              

Primarily assist in activities associated with transition from IVDD to IVDR regulatory approval of on-market in vitro diagnostic medical devices in global markets. Secondarily, assist in submission activities for a variety of device regulatory approvals including the CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.

- Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues in the geographic and discipline as relevant to assigned projects.

- May interface with regulatory authorities on regulatory and technical matters, as directed.

- May provide regulatory support on project teams.

- May assist in the creation of Operating Procedures and policy guidelines.

- May assist in review of labeling changes, as well as advertising and promotional materials.

- May assist as the internal regulatory consultant for on-market product issues. - May assist in review of proposed device changes.
 

Skills              

- Strong organizational skills and attention to detail required.

- Experience with Microsoft based applications and general knowledge of PC functions necessary.

- Ability to work in a fast-paced/entrepreneurial team environment.

- Results and goal oriented.

- High degree of initiative with the ability to work independently with some supervision.

- Excellent oral and written communication skills.

- Ability to prepare and present information to groups.

- Ability to plan and organize work while remaining flexible.

- Excellent time management skills.

- 2 years experience in a FDA regulated industry, or equivalent is preferred.

- Experience working in a cross-functional team setting is preferred.
   
Education         

 - B.S./B.A. in a science, engineering, or related technical field; or related work experience. 

Skills:

regulatory, compliance, regulatory compliance, regulatory submissions, regulatory affairs, quality specialist, regulatory specialist, regulatory requirements
Please review all application instructions before applying.

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