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Regulatory Engineer Labeling Medical Devices

Ledgent Technology

This is a Full-time position in Redmond, WA posted April 30, 2021.

Our medical technologies firm in Redmond, WA is looking for a Regulatory Engineer (Labeling Medical Devices) Job Summary The primary function is the determination of labeling requirements for electro-medical devices and accessories to international safety standards, regulations, and directives. Responsible for the development and maintenance of product labeling requirement documents based on the labeling technical standard checklist. This development project includes interfacing with Subject Matter Experts and team members across departments and meeting overall labeling timelines. The development process includes the review of product, packaging, and IFU labeling against a known set of requirements to determine the applicable labeling set, and providing rational explanation for the labeling decisions. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Works on problems of complex scope where data analysis requires evaluation of specific factors. Utilizes independent judgment within broad parameters to determine an appropriate solution. Assists in maintenance, and revision, of the labeling technical standard as requirements are added or updated. This includes the review of safety standards, Directives, Regulations, country specific, and business labeling requirements. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Essential Duties and Responsibilities Leads the preparation and revision of the product Labeling Requirements Matrix used to develop the product marking, labeling, and user documentation. Guides engineeringregulatory project teams in determining labeling requirements when designing new or revised labeling for products to be compliant. Helps create and maintain overall Labeling Requirements Matrix template. Ability to manage several projects and work on internal and external department teams. Provide a weekly status report. Implements engineering documentation of high complexity. Perform other duties as assigned. May attend project meetings to represent Regulatory Affairs. Qualifications A Bachelor’s degree in electrical engineering or related discipline. Strong time management skills Familiarity with EU labeling Directives and Regulations Familiarity with FDA labeling Regulations Excellent computer skills with mid-range knowledge of Word, Excel and PowerPoint Excellent written and verbal communication skills. Minimum 5 years experience with medical device product compliance. Familiarity with IECISO standards for medical devices, such as IEC 60601-1 and IEC 60601-2-4, and ISO 15223-1, Familiarity with country specific wireless labeling requirements Benefits We put our Ambassadors first. When it comes down to it, we know we can’t fulfill our Promise to our business customers without your com mitment. You represent our organization while on assignment. In return, we do our best to show our commitment to you. Our Ambassador Benefits package includes Medical, dental and vision coverage. It also includes 401k, sick time, holiday and much more. We are an equal opportunity employer. We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.