12 days old

Regulatory Affairs Associate

Kelly Services
Redmond, WA 98073
Our client, a top Medical Technologies firm, is currently seeking a **Regulatory Affairs Associate** for a 12-month temporary position with the opportunity for an extension. The position is located in Redmond, Washington AND/OR Remote.

By working for our client, you will be exposed to a large multinational company with revenues of over $14 billion dollars, work in a publicly traded company (NYSE), work in a fast-paced corporate environment and be an integral part to the Regulatory team.

**In addition to working with the worlds most recognized and trusted name in staffing, Kelly employees can expect:**

**-** **Competitive pay**

**-** **Paid holidays**

**-** **Year-end bonus program**

**-** **Recognition and incentive programs**

**-** **Access to continuing education via the Kelly Learning Center**

The hours for this position are as follows

+ Monday to Friday 8:00am-5:00pm (could be flexible)

**Pay Range: $52.98-$55.55/hour**

Your responsibilities will include (but not limited to):

Collect and enter global UDI attributes and global labeling information into predefined systems

Assist with collation of information for Technical Documentation Files and Declaration of Conformities Manage OEM / Accessory Declarations of Conformity and Certification

Assistance with regulatory agency deliverables when applicable

Support regulatory registration information entries into specialized software applications

Update RRA (Regulatory Release Authorization) when product registration for a country is completed

Create and maintain appropriate work instructions

Update and maintain product lists for FDA, Notified Body and other regulatory bodies that contain applicable clearance/approval pathway

Execute identified tasks for the Global Growth Project, including drafting and launching Engineering Change Orders (ECO), labelling updates and working with manufacturing to implement the changes and update Device History Records (DHR)

Engage in clear and timely communication with Regulatory Affairs, Marketing and Customer Service teams

Provide skilled technical support with minimal direction, which may include data coordination, data analysis, tracking and coding

You are required to have a high school diploma, intermediate MS Office skills and have excellent communication skills. You will be detailed oriented, have solid customer service skills, be able to multitask and be adaptable.

****Important information** : This position is recruited for by a remote Kelly office, not your local Kelly branch. If you have questions about the position, you may contact the recruiter recruiting for this position **however,** your resume should be uploaded via the **_SUBMIT RESUME_** button included within**

**Why Kelly** **** **?**

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**About Kelly** ****

At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.



Posted: 2020-11-18 Expires: 2020-12-19

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Regulatory Affairs Associate

Kelly Services
Redmond, WA 98073

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