Senior Regulatory Affairs Engineer

Reporting to the Sr. Manager, Regulatory Affairs, you will ensure FDA Class I, II and III medical devices products meet regulatory requirements through development, market clearance, and post marketing phases.

Its 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, and Mexico as a Great Place to Work.

Key Responsibilities:

As a trusted and credible regulatory advisor you will lead cross functional new product development cross functional teams comprising of Engineering, Manufacturing, Marketing, Quality, Clinical and Service, creating pre-market approval strategies. This effort will include preparation and submission of 510(k)s. PMAs, Letters to File, Technical Files, CB Reports and technical construction files, approving labeling and interpreting relevant clinical and safety standards.

You will also license and register products in the U.S., Canada, European Union, and other international locations.

A key deliverable will be to maintain  product compliance to domestic and international standards and regulations such as European Medical Device Directives (MDD), Canadian Medical Device Regulations, Australian Therapeutic Goods Regulations (TGA), Japan Pharmaceutical Affairs Law (PAL), UL, CSA, IEC 60601, JIS, ANSI/AAMI, FDA Quality System Regulations, ISO 13485 / CMDCAS, etc.

Your post market surveillance activities will ensure compliance to regulations through evaluation and timely submission of adverse event reports, and medical device reporting (MDR) submissions, corrections, removals, device listing and tracking.

Your critical thinking, risk management and creativity have helped you find solutions for complex regulatory challenges. Your outstanding communication skills have enabled you to effectively influence positive change.

Required Background:

A BS (Engineering preferred) and experience in a medical device, biotech, or highly regulated electronic manufacturing environment is required.

Solid knowledge of US FDA, Medical Device Directives (MDD)  and international medical device Quality Management System (QMS) to assure requirements of Quality System Regulation (QSR) 21 CFR 820, ISO-13485 / CMDCAS and related standards is needed for success.

Knowledge of product safety standards and telecommunication standards (i.e. UL, CSA, IEC, JIS and ANSI/AAMI) and ISO-14001 and Human Factors are a plus.

Welch Allyn - What a Career Should Feel Like.

Please refer to job code 4647 when responding to this ad.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Skaneateles, NY
County:	Onondaga County
ZIP Code:	13152
Pay Rate:	Open
Job Terms:	full time
Company:	WelchAllyn
Phone:	email only please
Fax:	email only please