202636 - Regulatory Affairs Associate
Industry
PRO
Region
NY-Upstate
City
Skaneateles
State
NY
Rate
Up to $40.62 DOE
Duration
12 months
Description
Chipton-Ross is seeking a Regulatory Affairs Associate for a contract opportunity in Skaneateles, NY.

RESPONSIBILITIES:
o Supports regulatory project plan execution
o Maintain awareness of regulatory requirements and ensure continued learning
o Maintain regulatory files in a format consistent with requirements
o Participate as an active team member of project teams as required
o Compile and prepare responses to questions from regulatory authorities according to plan
o Edit and proofread regulatory documentation
o Assist in preparation and review of labeling, SOP's, and other departmental documents
o Compile under supervision regulatory documents for submission
o Track status and progress of regulatory documentation
o Understand Regulatory Affairs' position in small project teams
Qualifications
o Knowledge of regulations
o Scientific knowledge
o Administrative and project management skills
o Ability to contribute to multiple projects from a regulatory affairs perspective
o Ability to multitask and prioritize
o Interpersonal and communication skills
o Technical system skills (e.g. word processing, spreadsheets, databases, online research)
o Proofreading and editing skills

REQUIREMENTS:
-Familiar with USA and OUS device regulations (specifically EU device regulations)
-Experience with RA strategy development
-Experience with working with Cross functional team members
-Experience with interaction with external Regulators (FDA, TUV)
-Experience with working with medical devices

EDUCATION:
Accredited Bachelor's degree or country equivalent in a relevant scientific discipline

SHIFT:
Full-Time
1st Shift

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Tyler Harrell
tharrell@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x307 or (800) 927-9318 x307

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.