Regulatory Affairs Associate Job

REGULATORY AFFAIRS ASSOCIATE needed for a CONTRACT opportunity with Yoh's client located in Warsaw, IN.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Knowledge of FDA regulations
- Labeling regulations
- Submissions

WHAT YOU'LL BE DOING:

- Perform and maintain regulatory affairs and regulatory compliance functions
- Communicate and coordinate with various departmental teams in implementing controls and measurements to ensure quality and regulatory compliance
- Provided regulatory support to multiple product design teams
- Analyze product changes and performed regulatory impact analysis for affected markets

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's Degree in life sciences, technical (engineering) or related field (or non-US equivalent)
- No formal RA experience required, two years preferred
- Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred
- A combination of education and experience may be considered
- Familiarity with US Federal Regulations and Guidance governing drug and device development (IND, IDE,NDA, ANDA, Orphan Drug designation, BLA
- Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA
- Ability to function well as a member of the team and build relationships between RA and other areas of the organization
- Strong attention to detail, ability to multi-task

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Advanced experience in the areas that may include preparation of dossiers for product registrations outside the US; preparation of submissions to the FDA strongly preferred

WHAT'S IN IT FOR YOU?

- This is your chance to shine while gaining exposure to the laws and regulations mandated by the health authorities, US and OUS, as they apply to the development, testing, approval, manufacturing, and commercialization of medical devices

GET HIRED, APPLY NOW!

RECRUITER: Jerome Adams

EMAIL:(see below)

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. J2WSEMW

Ref:

SFSF: LS