CenterWatch

17 days old

Regulatory Affairs Specialist II

Kelly Services
Irving, TX 75062
**Regulatory Affairs Specialist II**



**Project Name: Regulatory Strategy and Submissions for LCM/Supply Chain Projects**



**Description**



RA professional with experience in US FDA and EU medical requirements. The scope will include project support initiated by supply chain and Lifecycle management. Examples include: cost improvement projects, capacity expansions and facility changes, engineering/equipment changes, quality Improvement projects (changes in quality inspections or standards, test methods etc.), LCM projects (product changes post-launch, including labeling changes) and Procurement/Supplier changes.



**Project Goals**




+ Evaluate changes and provide regulatory impact assessment

+ Provide Regulatory feedback on submission strategy

+ Author and submit regulatory submissions to Health Authorities and affiliates

+ Ensure regulatory affairs files are maintained to support compliance with regulatory requirements

+ Provide support to audit and Health Authority requests as necessary

+ Authorship and submission of PMA Supplements (30-Day Notices) and EU Change Notice submissions for manufacturing process changes, supplier changes and cost improvement projects



**Qualifications**




+ Bachelors degree with at least 2 years of related experience

+ Knowledgeable in FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical devices

+ Effective oral and written communication

+ Strong interpersonal and influencing skills

+ Computer skills, including proficiency with Microsoft Word, Excel, PowerPoint and Project



**Location**




+ Irving, Texas



**Travel**




+ Occasional, as needed, no more than 10 %








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




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

Categories

Posted: 2019-11-04 Expires: 2019-12-05

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Regulatory Affairs Specialist II

Kelly Services
Irving, TX 75062

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast