Regulatory Specialist

  • Location
    Valencia, California
  • Job type
    Contract/Temp to Hire
  • Salary
    $ 75000 - $ 90000 / Year

Adecco is assisting a local client in recruiting for a Regulatory Specialist with Manufacturing experience in the Santa Clarita area. This is a Direct Hire. Please review the details below and if you meet the qualifications listed please Apply Now!

 

RESPONSIBILITIES:

Draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines. Interface with outside organizations and/or internal associates in assembling regulatory materials.

 

May interface directly with outside counsel and governmental regulatory personnel to facilitate the review and approval of regulatory applications.

 

Represent Regulatory Affairs on assigned project teams through all phases of product development Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.

 

Review and interpret scientific literature and summarize effectively in writing. Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends. Ensure training and compliance with global quality system regulations.

 

Perform other essential tasks assigned, i.e. creating departmental SOPs.

 

REQUIREMENTS:

BA/BS or MS degree in Life Sciences, Engineering, or health care-related discipline.

Five or more years of experience in the medical device industry, preferably in a small manufacturing/R&D environment that includes medical writing, clinical studies, regulatory submissions, and regulatory reviews.

 

Must have experience developing, writing, and organizing all aspects of the IDE/PMA/510(k)'s.

 

Ability to independently analyze and interpret novel clinical, medical and scientific data.

 

Current knowledge of U.S. FDA and global (Canada, Australia, European Union, Latin America, India, China, etc.) regulatory requirements within the medical device industry.

 

Excellent organizational skills and attention to detail.

 

Strong analytical, management, communication and interpersonal skills.

 

Good knowledge of MS Office, Internet, databases, etc.

 

Excellent writing skills and the ability to write scientific summaries.

 

Must be able to handle multiple assignments and perform in a diverse cross-functional team environment.

 

Adecco provides one of the most comprehensive benefits package in the industry to contract workers. Benefits are available to you as a contractor after one week of employment. Click on Apply Now to be considered for this Regulatory Specialist position in the Santa Clarita area or any related opportunities with Adecco.

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled



  • Apply with Adecco

Reference number US_EN_99_025142_11880505