Regulatory Affairs / Quality Assurance Director

Enhance your career by putting your valuable experience to work in a great team environment while contributing to the success of major biotech, pharmaceutical and medical device companies.

 

Compliance Team, Inc. offers exciting opportunities for top-notch professionals with strong biotech, pharmaceutical and/or medical device industry experience. Our client-company, located in the Chicago, IL area, is currently seeking talented, highly-motivated individuals for the full-time permanent position described below.

 

The Regulatory Affairs / Quality Assurance Director is responsible for implementing the quality system and managing the regulatory document flow - writing reports, protocols and other documents, analyzing and summarizing data for regulatory submissions throughout the product lifecycle.

 

The Regulatory Affairs / Quality Assurance Director responsibilities include: Completes QSR vendor audits and internal department audits.Conducts QSR/GMP training annually for all personnel and as needed for new personnel.Performs complaint investigations and trending, Assists in the planning and writing of summaries, protocols, reports and other regulatory documents pertinent to FDA medical device submissions Performs and summarizes statistical analyses of study resultsManages document approval flow, ensures completion of all the adequate documentation for the projects. Ensures guidance to the organization in respect to compliance to most current regulatory requirements (FDA, CLSI, CAP, CLIA…). Manages the assembly, technical review and approval of regulated documents for assigned projects Support software and process validation requirements.Directs day-to-day activities of the Document Control Coordinator 



Requirements:

In addition to the responsibilities stated above, the position requires the following skills and experience:Minimum B.S. in life sciences, advanced degree is preferred.At least 8 years of quality assurance and regulatory affairs leadership experience within the medical device industry.The ideal candidate will be familiar with FDA regulations including 21 CFR and GMP/GCP/GLPExperience with medical device Regulatory Submissions for 510(k) filingsCLIA requirementsCLSI (NCCLS) standards and guidelinesExcellent writing and communication skills. Fluent command of spoken and written English.Proficiency with Microsoft Office, especially Word and Excel, is a must.Ability to work independently and to take a leadership role in the QA/RA processes is a must.Ability to multitask and manage multiple and changing priorities.Ability to work under pressure and adhere to deadlines.Flexibility and excellent interpersonal, organizational, and communication skills are required.

 

Compliance Team, Inc. provides validation services, compliance consulting services, and technical staffing services as a solution to support our pharmaceutical, biotech, and medical device client’s permanent and temporary technical staffing needs. Please visit our web site at www.complianceteaminc.com.

 

Employer Information:

 

The client-company associated with this position will not receive your resume or be notified of your interest in this position without your prior approval. Please forward any inquiries or questions regarding this opportunity to jobs@complianceteaminc.com .

 

Contact Information:

For consideration, please send an MS Word copy of your resume via email indicating the position of interest to mailto:jobs@complianceteaminc.com?subject=Validation%20Engineers%20and%20Quality%20Assurance%20Professionals,%20Multiple%20Openings .