Manager of Compliance/Regulatory

In Santa Barbara, CA with MPA Associates posted 3 months ago

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Medical Device Job Description

DUTIES
* Responsibility as a management representative will include liaison with external parties on matters relating to the quality management system.(In house, vendors & customers)
* Develop and implement internal Quality/Regulatory documentation processes to meet FDA & ISO and other regulatory compliance requirements.
* Develop and implement a cross functional internal audit program/team to ensure all regulatory requirements are met.
* Lead and provide expert advice in the areas of compliance QSR, ISO13485.
* Monitor and report on all regulatory compliance activities within the business units.
* Lead assigned due diligence and new business integration activities as required.
* Develop QMS initiatives to drive simplification and standardization throughout the organization.
* Manage overall coaching, training, development and succession plans for the regulatory and quality assurance teams.

QUALIFICATIONS
* BS in Science or Engineering and Lead Auditor certification or ASQ Professional Certification
* 5 -8 years minimum manufacturing background in medical device or pharmaceuticals.
* 5 -8 years management experience in Compliance & Regulatory with FDA and other regulatory bodies.
* Ability to effectively interface interdepartmentally.
* Perseverance in investigating alleged non-compliance.
* Effective organizational, technical and problem solving skills.
* Computer skills in word processing, spreadsheets, and databases highly desirable. Proven success with FDA and Notified Body interface.
* Understanding of the internal Quality Management System, United States Quality System Regulation (21 CFR 820), the Medical Device Directives, ISO 13485, CAN/CSA–ISO 13485 and all other applicable medical device regulations.
* Experience and demonstrated understanding of quality assurance in a medical device manufacturing and sales environment.
* Experience with silicone and molding or extrusion processing highly advantageous.
* Effective oral, written, documentation and presentation skills.

To Apply…

Email resume to Mike at mpa@mpahire.com or call 330.280.3432