- 196480 - Regulatory Affairs Specialist V
- $51.07 to $91.36 DOE
- 4 months
Chipton-Ross is seeking a Regulatory Affairs Specialist V for an opening in Skaneateles, NY.
Other duties may be assigned. Performs regulatory assessment on all customer complaints. Performs MDR and Vigilance evaluations and completes filings as required. Reviews technical publications and revisions to standards to ensure compliance with regulatory and industry standards. Prepares and maintains Regulatory submissions for US and OUS which may include 510(k), STED Files, Design Dossiers and similar submissions for ROW (Rest of World). Creates, maintains, and revises STED File/Design Dossier documentation to ensure compliance with current regulatory standards and product information. Supports international registration activities required by our customers or international distributors. Supports regulatory projects and OUS regulatory relations with Authorized Representatives and In Country Caretakers. Reviews and approves sales and marketing literature to ensure regulatory compliance. Assist with annual Regulatory activities (FDA Registration, Canadian Device Licenses, FURLS Listing, State Licenses, CFG). Assist with necessary registrations and licensing for new products and acquisitions. Supplies all regulatory agencies with requested information. Assist with customer relations for QA/RA which may include but is not limited to: o Ensures customers receive any required quality documentation and product related information o Completion of customer surveys and responding to the customer. Supports regulatory audits. Perform labeling review and verification activities. Participate in Risk Management and Post Market Surveillance as part of a cross-functional team.
Quality System knowledge including the quality manual, quality policy, and applicable procedures and work instructions. Establish, implement, and maintain the quality system in accordance to FDA Quality System Regulations, ISO 13485, European Union Medical Device Directives, Japanese Ministry of Health and Welfare, and Canadian Medical Device Regulations. Completes and documents all required quality, business, and departmental training
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 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.