Regulatory Affairs Specialist Job

REGULATORY AFFAIRS SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in the Mission Bay Area of San Francisco, CA.

TOP SKILLS SHOULD YOU POSSESS:

- Excellent word processing, and graphic documentation skills are required
- Strong computer skills in Word, Excel and Adobe Acrobat, with a working knowledge of electronic publishing/file management systems are an asset
- Strong oral and written communication skills are required

WHAT YOU'LL BE DOING:

- Duties Under the direction of senior regulatory affairs staff, assists in compiling and preparing regulatory submissions for the Company and partner sponsored global regulatory submissions, including 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.
- Assists in gathering and assembling information necessary for submissions in accordance with regulations and relevant guidelines.
- Under the direction of senior regulatory affairs staff, maintains regulatory submissions and correspondence for Company sponsored projects, and all company related sections for partner sponsored projects.
- Follow general instructions to complete projects and organizes workday to complete mid-term assignments

WHAT YOU NEED TO BRING TO THE TABLE:

- A minimum of a Bachelor's Degree in a scientific discipline is preferred; equivalent experience may be accepted.
- A minimum of two (2) years related industry experience is required.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- A minimum of two (2) years hands-on Regulatory Affairs experience is preferred.

GET HIRED, APPLY NOW!

RECRUITER: Will Thompson

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. If you are an individual with a disability and you require an accommodation in the application process, please email

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