Location: Skaneateles, NY

Department: Regulatory Affairs

Relocation Provided: Yes

Education Required: Bachelors Degree

Experience Required: 11 - 15 years

Position Description:
Reporting to the Director of Regulatory Affairs, you will be responsible for developing, maintaining, and implementing the Company’s risk management processes and procedures worldwide. Your ability to apply advanced risk assessment and statistical techniques will be essential in evaluating and ensuring the safety & efficacy of Welch Allyn’s products.

It’s your life. Work well. You would be joining a privately held global manufacturer of innovative medical diagnostic equipment and patient monitoring systems founded in 1915 and recognized in the US, Ireland, Germany and Mexico as a Great Place to Work.

Position Requirements:
A BS degree in Engineering coupled with demonstrated experience in software driven medical device manufacturing and NPD environment is required, along with knowledge of FDA’s regulations, GHTF guidance’s, ISO-13485, ISO-14971, etc.

You must be a team player, reflecting high integrity as well as a strong work ethic and are able to set and meet aggressive timelines. Six Sigma training and/or certification is highly desired. Willingness to travel globally is also required.

Welch Allyn – What a Career Should Feel Like

Position Attributes:
As the Sr. Manager of Global Risk Management you are a key member of the Quality & Regulatory Team and will lead the development and implementation of risk management and reliability analysis processes throughout the life cycle of the Company’s products.

Your knowledge of relevant FDA regulations, GHTF standards and guidance documents, as well as other international directives and standards, such as ISO-14971, ISO-13485, ISO-9000, etc., will be essential in establishing the necessary risk and reliability procedures for both pre and post market activities. Your work will have a direct impact on helping the Company achieve its strategic objectives by ensuring new and existing products are meeting safety, efficacy and reliability requirements.

Working with New Product Development (NPD) Teams you will help proactively analyze the reliability of individual components and finished device designs. You will also work with other corporate functions such as Clinical Affairs, Legal and Current Product Engineering to conduct risk assessments and failure investigations of existing products. This will include initiating and completing health risk evaluations (HREs) & health hazard evaluations (HHEs) as appropriate to evaluate actual or potential failures and determine associated risk profiles and remedial actions. As required you will also convene and coordinate the Quality Review Board to ensure systematic and objective reviews of evaluation results.

As the a owner of the global risk management processes you will be responsible for ensuring the Company stays abreast of the relevant worldwide regulations, standards and techniques for risk and reliability assessment. Your toolbox will include techniques such as, FTA, UFMEA, DFMEA, PFMEA, Weibull Plotting, HALT, HASS, etc.

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