Regulatory Compliance Specialist

Our client is a mid sized manufacturer of clinical diagnostic products with cutting edge technology and an aggressive growth plan for the US and Europe.  We are currently recruiting for a Regulatory Affairs or Quality professional that has proficiency with GMP regulations for devices and ISO 13485 compliance.  Job Purpose:Maintains regulatory compliance by reviewing, evaluating, and measuring regulatory compliance requirements against operations and operational changes. Duties:§ Helps departments meet requirements of domestic and foreign regulatory agency requirements by preparing departments for compliance with inspection procedures.§ Provides compliance information by identifying, interpreting, and disseminating new regulatory trends, expectations, and compliance documents.§ Develops action plans to correct regulatory compliance deficiencies by assessing the state of compliance with regulations; identifying potential non-compliance issues.§ Prepares regulatory filings by helping with drafts, reviews, and approvals; applying US regulations and practices pertaining to the manufacture and testing of pharmaceutical biological products and medical devices.§ Improves quality results by completing projects; studying, evaluating, and re-designing processes; implementing changes.§ Updates job knowledge by participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.§ Enhances operations compliance and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments. Skills/Qualifications:BS degree in a scientific discipline and demonstrated proficiency in FDA device GMP and ISO 13485 compliance.  Experience in the follow areas is helpful: Biohazard Safety, Sterilization, FDA Health Regulations, Trial Development, Process Improvement, Results Driven, Written Communication, Documentation Skills, Research Skills, Equipment Calibration, Internal Communications Contact Email: Apply by Email Company:  Lab Support, a division of On Assignment Job Status:  Full Time, Temporary/Contract/Project, Employee Category:  Biotech/R&D/Science Apply Now! Email this Job to a Friend Click here to see all company opportunities