197118 - Regulatory Affairs Specialist
Industry
PRO
Region
CA-S.Cali-Los Angeles/Orange Counties
City
Fremont
State
CA
Rate
$45 to $53.00 DOE
Duration
6 months
Description
Chipton-Ross is seeking a Regulatory Affairs Specialist for an opening in Fremont, CA.

RESPONSIBILITIES:
• Initiation, collection, and coordination of information of regulatory documents for various purposes.
• Preparation and maintenance of product technical files for CE marking. Experience of EU IVDR or MDR a plus
• Organization and preparation of documents for international submissions, including drafting reports, and preparing documentation for submissions
• Coordination with international counterparts to obtain product approvals and renewals.
• Maintaining logs and trackers.
• Organize, update, and maintain regulatory documentation in accordance with department and company procedures.


REQUIREMENTS:
• Excellent writing skills, and an ability to generate clear, concise documents
• Strong planning and organizational skills.
• Proficient with computer and standard software programs, especially Excel, Word, Abode Pro, Teams, SmartSheet, Agile, Master Control, Oracle.
• Self-starter starter, with the ability to work and learn independently.
• Strong attention to quality/detail.
• Ability to handle multiple tasks and priorities.
• Excellent organizational, time management, and administrative skills.

EDUCATION:
Minimum BS or equivalent education with 1-3 years of relevant experience in Regulatory Affairs or Quality Assurance. Science background preferred.

SHIFT:
Full-Time

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

Contact
Bryan Nguyen
bnguyen@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x223 or (800) 927-9318 x223

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.