Director Of Regulatory Affairs

Director Of Regulatory Affairs
Port Washington
Pay Range:
# of Hours:
Employment Duration:
Full time
Director of Regulatory Affairs
Staff Management - SMX is recruiting for an exciting opportunity as the Director of Regulatory Affairs for our client at their busy manufacturing facility in Port Washington, WI.
The Director of Regulatory Affairs has the responsibility to provide policy, monitoring, and reporting of all quality activities required to comply with regulatory agencies (FDA, EPA, OSHA, DNR, etc.) for the company.
+ Comprehensive Medical, Prescription Drug, and Dental Plan
+ Company paid Life and AD&D Insurance
+ Short and Long-Term Disability
+ Voluntary Life & Disability Program Eligibility
+ Medical and/or Dependent Care Flexible Spending Account
+ Prescription Safety Glasses
+ 401(k) Savings Plan with Match
+ Employee Assistance Program
+ Vacation and Paid Holidays
+ Direct all activities within the Quality Compliance function.
+ Provide leadership and direction to establish and achieve all Quality Compliance goals and objectives.
+ Oversee budget for Quality Compliance function.
+ Direct development and enforcement of all corporate compliance standards for all facilities.
+ Lead in the development of quality related compliance procedures and policies and ensures consistency between sites.
+ Develop, establish, and ensure the regulatory requirements of the Quality, Safety, Health, and Environmental systems throughout the organization.
+ Provide guidance and oversight to all Quality System Managers in accordance with compliance standards.
+ Initiate and oversee internal and external audits, and review corrective actions for adherence to compliance requirements.
+ Provide advice and information on all regulated communication on compliance and regulatory issues.
+ Review corporate documents for compliance to regulated requirements.
+ Interact with regulated agencies on all regulated visits and audits and regulated product customer audits.
+ Work in conjunction with Director of Quality to implement all regulated product requirements, cGMP requirements, and company standards.
+ Bachelor?s Degree with emphasis in natural science.
+ 5 years+ in quality assurance or quality control in an FDA regulated industry.
+ The ability to read, analyse, and interpret business information, journals, technical procedures, or governmental regulations.
+ Excellent communication skills (written and verbal) to write reports and findings and present to all elvels of management in a clear and concise manner.
+ Strong project management skills.
+ Advanced mathematical concepts such as exponents, logarithms, quadratic equations and permutations, as well as, the ability to apply such operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, sampling theory and factor analysis.
+ Excellent customer relationship management experience and the ability to solve complex problems effectively to meet and/or exceed customer expectations.
+ Exceptional organizational skills, along with strong attention to detail.
+ Excellent multi-tasking skills along with the ability to perform well under pressure while maintain composure and respect for everyone.
+ Demonstrated excellence in Microsoft Office (Word, Excel, Access, Power Point), experience with Google mail and apps.
+ Proven ability to maintain confidentiality and discretion with information.
+ The ability to work autonomously, however mostly working as part of a team/
+ The ability to manage high volume workload while remaining focused on meeting project and customer objectives.
+ The ability to think on your feet, work under pressure, and navigate through quality assurance/quality control issues.

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