Manufacturing/Quality & Regulatory Affairs Director Job in Warsaw, Indiana US

Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer is a worldwide leader in designing, developing, manufacturing and marketing orthopedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 27 countries around the world and sells products in more than 100 countries. Zimmer's 2010 sales were approximately $4.2 billion. The Company is supported by the efforts of more than 8,000 employees worldwide.

 

Reconstructive

Zimmer reconstructive orthopedic implants restore joint function lost due to disease or trauma in joints such as knees, hips, shoulders and elbows. Zimmer Reconstructive represents the largest segment of Zimmer business, with about 80 percent of total Zimmer global sales. Zimmer is a global market leader in both Hip and Knee products, and is emerging as a leading company in Extremities. Zimmer continues to develop the industry's most innovative technologies, including Zimmer Patient Specific Instruments, Trabecular MetalTM Technology, and Zimmer Gender SolutionsTM. Primary Zimmer Reconstructive locations are in Warsaw, Indiana, and in Winterthur, Switzerland.

 

WARSAW, INDIANA- Home to Zimmer Corporate offices, Manufacturing, Distribution and Research and Development centers, Warsaw is located in north central Indiana about an hour from South Bend or Fort Wayne and three-hours east of downtown Chicago. Warsaw and the surrounding Kosciusko County has a population of about 75,000. Warsaw is known as the "Orthopedic Capital of the World," with many orthopedic-related companies in the area, including three of the world's largest. With more than 100 lakes the county is historically known as a major summer resort area.

 

Job Summary

This position is responsible for oversight of all facets of regulatory and quality support for Zimmer Recon development. Position is responsible for oversight of the development of regulatory submissions; departmental projects; development of or creation and review of labeling; provision of guidance and consultation for domestic and international regulations; interaction with governmental agencies, ensuring compliance with quality system requirements, and overseeing/managing a staff of quality and regulatory professionals. The Director is also responsible for providing Regulatory and Quality guidance to the company, including Zimmer Recon executive management and the Legal department, and must be aware of current developments and potential changes and

opportunities in U.S. and other regulatory jurisdictions.

 

Principal Duties Responsibilities

-Oversee development of international and domestic regulatory submissions, including 510(k), IDE, and PMA submissions.

-Oversee pre-submission meetings with FDA and notified bodies, review of proposed labeling to

ensure intended use and claims are supported for use, and review product process changes to ensure

compliance to domestic and international regulations, as well as impact to domestic and international

submissions.

-Interface with regulatory bodies such as FDA, and notified body during routine audits.

-Interprets and applies FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization.

-Keeps all areas of Zimmer informed of regulatory requirements and emerging issues which may affect the registration approval of products.

-Manage the assigned Quality functions in support of customer satisfaction through the timely, efficient support of product development activities, including design reviews, verification, validation, and transfer.

-Develops departmental strategy and manages departmental function to achieve key objectives; is alert to the potential to use new technology to achieve greater efficiencies.

-Manages and develops personnel to lead them to higher performance levels and maximize their career potential.

-Establishes QA/RA policy and procedures and ensures compliance with them.

 

Expected Areas of Competence (KSA's)

Medical device quality assurance and quality systems experience is required.

Proficient in FDA medical device regulations with an understanding of the global regulatory environment.

Manufacturing, and product development experience as well as orthopedic knowledge is desirable.

Ability to foster individual and group development by identifying and arranging appropriate assignments, formal training or other experiences.

Develops emerging talent to assume new or increased responsibilities in the future.

Ability to develop and champion an organizational culture that promotes behaviors that lead to superior business performance.

Exhibits good business sense, capable of identifying business needs and opportunities relative to products and services.

Acts in a balanced and ethical manner when dealing in gray areas of regulation.

Demonstrated ability to learn key orthopedic product and process knowledge quickly.

Strong written and verbal communication and interpersonal skills.

 

Education/Experience Requirements

Bachelor's degree in relevant field (e.g., engineering, materials science or life science) is required, and Master’s degree is preferred. Ten to 15 years of experience in Quality and Regulatory. Extensive experience in medical device operations which enables first-hand knowledge of manufacturing, QC/QA and interface with RD.

Proven success in a leadership role.

CQE/CQA Preferred.

 

APPLY NOW online at:    https://jobs.zimmer.com/sap/bc/webdynpro/sap/hrrcf_a_posting_apply?PARAM=cG9zdF9pbnN0X2d1aWQ9RTE3MUZGOTgyRjdBNzBGMUI4MEIwMDE1MTc1OUE2Q0EmY2FuZF90eXBlPUVYVA%3d%3dsap-client=500sap-language=EN