- 188140 - Regulatory Affairs Specialist
- CA-S.Cali-Los Angeles/Orange Counties
- West Hills
- Up to $44.99 DOE
- 4 mos
- Chipton-Ross is seeking a Regulatory Affairs Specialist for an opening in West Hills, CA.
Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests. Represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for global product development, labeling, and/or promotional issues. Attends product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis/risk assessment reviews, timeline development/reviews, and V & V reviews. Develops the regulatory strategy for project team(s). Applies advanced regulatory expertise to the evaluation and solution of submission problems. Actively reviews and edits documents associated with product development meetings. Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change. Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines. Review and interpret scientific literature and summarize effectively in writing. Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends. Ensure training and compliance with global quality system regulations. Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel. Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing. Draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines.
Minimum of 3 years experience in the device/diagnostic area of regulatory affairs. Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards. Knowledge of Canadian and Japanese device regulations desired.
Accredited Bachelors Degree in science or life science is required.
Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.
420 Culver Boulevard
Playa Del Rey, CA 90293
Phone: (310) 414-7800 x340 or (800) 927-9318 x340
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.