199687 - Regulatory Affairs Specialist
Industry
PRO
Region
NY-Upstate
City
Remote
State
US
Rate
$27.34 to $40.62 DOE
Duration
12 months
Description
Chipton-Ross is seeking a Regulatory Affairs Specialist for a remote contract opportunity.

RESPONSIBILITIES:
o Initiate and develop complex regulatory project plans
o Identify & prioritize key areas of regulatory risk
o Provide regulatory device to project teams.
o Respond to complex questions from regulatory authorities within strict timelines
o Compile and submit in a timely manner, regulatory documents according to regulatory requirements
o Maintain and update device listing regulatory authorizations
o Manage regulatory activities relating to specific portfolio of products/projects
o Prepare, review. and approve labeling and SOP·s
o Lead or represent Regulatory Affairs in project teams
o Provide guidance and coaching for areas of responsibility to lower level team members
o Monitor applicable regulatory requirements
o Create and maintain regulatory files in a format consistent with requirements

REQUIREMENTS:
o Knowledge of regulations
o Solid Understanding of EU MDR and ancillary directives
o Scientific knowledge
o Project management skills
o Manage multiple projects , and deadlines
o Ability to multitask and prioritize
o Interpersonal and communication skills
o Strong negotiation skills
o Technical system skills (e.g. word processing, spreadsheets, databases, online research)
o Ability to work effectively in multinational/multicultural environment
o Ability to identify compliance risks and escalate when necessary


EDUCATION:
Bachelor's degree or country equivalent in a scientific discipline
Minimum of 5 years regulatory or equivalent experience within a pharmaceutical and/or medical device company, CRO, or similar organization

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.