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Manager of Quality Systems and Regulatory Compliance
Our client, a leader in the Medical Device/ Pharmaceutical industry and in applying the principles of biotechnology to medical devices has built a fully integrated medical device company with thousands of products for a number of medical specialties. They are experiencing significant growth and are in search of a Manager of Quality and Regulatory Compliance
SUMMARY DESCRIPTION
The Regulatory Compliance Manager shall interface between the plant facility and Corporate Regulatory Affairs. This function shall participate in the development, implementation and distribution of all Quality System Documentation to ensure that the development, manufacture and distribution of medical products is in compliance with company policies and procedures, US. Food and Drug Administration Regulations, ISO 13485:2003 Standard, European Medical Device Directives, Canadian Medical Device Regulations, Japanese QMS Ordinance (Ministerial Ordinance No. 169), Australian Therapeutic Goods (Medical Devices) Regulations 2002 (No. 236) and other International Regulations. This position will also oversee the Training program and Internal/Supplier Auditing system
RESPONSIBILITIES
· Review and approval of validation protocols, completion reports, Engineering Change Orders, and nonconformance reports
· Serves as Management Representative for compliance with ISO 9001, ISO 13485, ISO 14971, CMDR, and the Medical Devices Directive
· Assure complete and timely completion of annual reports for PMA products manufactured at the facility
· Plan, prepare and review domestic and international regulatory submissions for products manufactured at the facility
· Serve as the Regulatory representative for project teams
· Review product and process changes for impact on existing regulatory approvals, clearances, and notification requirements, for conformance with Design Control regulations and standards, and internal Standard Operating Procedures
· Participate, in conjunction with Quality Assurance, in FDA inspections, ISO audits and customer audits at the facility
· Participate on new product development project teams as site Regulatory Affairs representative
· Manage the change control program, for review and approval of vendor supplied and in-house printed labeling for product manufactured at the facility and oversee review / approval of in-house computer generated product labels
· Support investigation of complaints, nonconforming raw materials, in-process product or finished goods as necessary
· Support implementation of ISO 14971:2007
· Manage Product Development Quality Assurance Staff to ensure that all project development activities conform to internal SOPs and regulatory requirements
· Participate in recalls
DESIRED MINIMUM QUALIFICATIONS
· Minimum 8 years experience in the Medical Device Industry, with a minimum of 5 years direct experience in Regulatory Affairs
· Bachelor’s degree in scientific discipline. Master’s degree preferred.
· Demonstrated thorough knowledge of FDA regulations, ISO 9001, ISO 13485, ISO 14971, CMDR, Medical Device Directive Regulation (93/42EEC) and other National and International regulations and standards
· Demonstrates excellent organizational and communication skills and a high degree of attention to detail
· Demonstrated computer skills. Capable of working in an Oracle Enterprise Resource Planning (ERP) system a major plus
COMPENSATION
120K base salary, (Compensation commensurate with experience and salary history), annual target bonus and benefits package.
For confidential consideration, please forward your resume in a Word document to
bthornton@kleinhersh.com
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