Regulatory Affairs Associate III Job in Irvine, California US

COMPANY INFO:

 

NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a Regulatory Affairs Associate III

Our client is developing leading positions in seven major therapeutic areas.

Regulatory Affairs Associate III needed in Irvine, CA

Job Description:
•              Represent regulatory affairs on product development and commercialization teams related to Transcatheter Heart Valve products.
•              Will monitor proposed and current global regulations and guidance, and will advise on impact of such regulations and guidance on the company within the scope of assigned project(s) as it relates to labeling and advertising.
•              Responsible for regulatory review for claims support of promotional material, labeling content, product and process changes, and product documentation.

WORK EXPERIENCE REQUIREMENTS
•              A minimum of three years of experience within medical device regulatory affairs is required.
•              Experience with Class III devices preferred. Relevant experience includes, interventional cardiology, stents, implantable device, catheter delivery systems, orthopedics, cardiac surgery, heart valves or other innovative PMA devices.
•              Experience in preparing domestic and international product submissions preferred.
•              A Bachelors degree is required. 
•              Must be competent in applying the appropriate global regulatory requirements for new products or product changes as it relates to labeling and advertising of class II and III devices. Requires familiarity with new product development systems.
•              Must possess a strong working knowledge of US regulations that affect Class II and/or Class III devices; and comprehensive knowledge of global regulation.
•              Must have strong written and verbal communication skills, and have experience working on cross functional project teams.
•              Strong ability to problem solve and apply analytical thinking is required.

KEYWORDS:

Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor

 

 

MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.

 

 

PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!