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REGULATORY COMPLIANCE SPECIALIST - (BB10386)
Job Field: Legal Jobs
Location: Carlsbad, CA
Salary: $Not stated
Location: Carlsbad, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Regulatory Compliance Specialist - (BB10386)Job Requisition ID: BB10386Job Title: Regulatory Compliance SpecialistJob Type: Full-TimeLocation: Carlsbad, CAPost Date: 10/05/2012Job Description:SUMMARYThis position is responsible for providing Quality Management System compliance support within the Compliance department. The Compliance department encompasses activities related to Documentation Control, Change Control, Corrective Action Systems, Agile Administration, Field Actions/Recall, Internal Audits, and Quality Metrics. In this capacity, the Compliance Associate will focus on assisting in the establishment, implementation, and verification of company wide QMS systems for regulatory compliance.ESSENTIAL DUTIES AND RESPONSIBILITIES· Assists in establishing and implementing effective operational disciplines, methodologies and improvements in areas related to product/process quality and regulatory compliance.· Plans, analyzes and implements programs and procedures for increasing regulatory compliance· Leads the Internal Audit program by planning, coordinating, and managing internal audits, providing auditor training as required.· Leads the Corrective Action system to ensure that appropriate corrective and preventative measures are implemented where negative product/process quality trends are identified and CAPA system is effective.· Serves as Lead Coordinator for all field action (recall) activities.· Develops, reviews, and approves as requested, quality system documents for compliance with applicable regulatory requirements.· Supports the Customer Complaint system to ensure timely and effective investigation and actions for customer complaints.· Supports the medical device reporting (MDR) submittal process for adverse event reporting.· Supports the establishment of written Documentation Control and Change Control procedures.· Assists in the definition and documentation of organizational training activities, including requirements for record retention, retraining and disciplinary activities.· Trains Alphatec Spine personnel on Quality System Compliance to ensure procedures and processes are properly followed and documented.· Prepares technical reports, certificates and presentations as needed.· Communicates with engineering, marketing, and production departments on developing and improving compliance.· Maintains regular and consistent attendance at the normal worksite· Performs other duties as assigned.SUPERVISORY RESPONSIBILITIESNone.QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.* Medical Device regulatory knowledge with FDA Quality System Regulations (21 CFR 820), ISO 13485, and the Medical Device Directive (93/42/EEC as amended) desired.* Strong planning, organizational, and time management skills.* Detail oriented and possess solid math skills* Excellent communication and interpersonal skills required to communicate effectively with all levels, both internal and external to the organization* Self-directed, self starter that possesses ability to prioritize multiple projects and works independently as well as in a team environment.* Ability to solve practical problems and deal with a variety of changing situations under stress.* Computer literacy applied to scheduling and data management.EDUCATION and/or EXPERIENCEBachelor’s Degree in Engineering or related field preferred, or equivalent work experience2-5 years, preferably in a medical device manufacturing environmentCERTIFICATES, LICENSES, REGISTRATIONSRABQSA ISO 13485 Lead Auditor Certification preferred.We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
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<tr><td valign="top" width="450"><b>Regulatory Compliance Specialist - (BB10386)Job Requisition ID: BB10386Job Title: Regulatory Compliance SpecialistJob Type: Full-TimeLocation: Carlsbad, CAPost Date: 10/05/2012Job Description:SUMMARYThis position is responsible for providing Quality Management System compliance support within the Compliance department. The Compliance department encompasses activities related to Documentation Control, Change Control, Corrective Action Systems, Agile Administration, Field Actions/Recall, Internal Audits, and Quality Metrics. In this capacity, the Compliance Associate will focus on assisting in the establishment, implementation, and verification of company wide QMS systems for regulatory compliance.ESSENTIAL DUTIES AND RESPONSIBILITIES· Assists in establishing and implementing effective operational disciplines, methodologies and improvements in areas related to product/process quality and regulatory compliance.· Plans, analyzes and implements programs and procedures for increasing regulatory compliance· Leads the Internal Audit program by planning, coordinating, and managing internal audits, providing auditor training as required.· Leads the Corrective Action system to ensure that appropriate corrective and preventative measures are implemented where negative product/process quality trends are identified and CAPA system is effective.· Serves as Lead Coordinator for all field action (recall) activities.· Develops, reviews, and approves as requested, quality system documents for compliance with applicable regulatory requirements.· Supports the Customer Complaint system to ensure timely and effective investigation and actions for customer complaints.· Supports the medical device reporting (MDR) submittal process for adverse event reporting.· Supports the establishment of written Documentation Control and Change Control procedures.· Assists in the definition and documentation of organizational training activities, including requirements for record retention, retraining and disciplinary activities.· Trains Alphatec Spine personnel on Quality System Compliance to ensure procedures and processes are properly followed and documented.· Prepares technical reports, certificates and presentations as needed.· Communicates with engineering, marketing, and production departments on developing and improving compliance.· Maintains regular and consistent attendance at the normal worksite· Performs other duties as assigned.SUPERVISORY RESPONSIBILITIESNone.QUALIFICATIONS The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.* Medical Device regulatory knowledge with FDA Quality System Regulations (21 CFR 820), ISO 13485, and the Medical Device Directive (93/42/EEC as amended) desired.* Strong planning, organizational, and time management skills.* Detail oriented and possess solid math skills* Excellent communication and interpersonal skills required to communicate effectively with all levels, both internal and external to the organization* Self-directed, self starter that possesses ability to prioritize multiple projects and works independently as well as in a team environment.* Ability to solve practical problems and deal with a variety of changing situations under stress.* Computer literacy applied to scheduling and data management.EDUCATION and/or EXPERIENCEBachelor’s Degree in Engineering or related field preferred, or equivalent work experience2-5 years, preferably in a medical device manufacturing environmentCERTIFICATES, LICENSES, REGISTRATIONSRABQSA ISO 13485 Lead Auditor Certification preferred.We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
KEY REQUIREMENTS:
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