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9 days old

Sr. Regulatory Affairs Specialist

Kelly Services
Madison, WI 53703
Kelly Services Outsourcing & Consulting Group (OCG) has an opening for a Sr. **Regulatory Affairs Specialist** with MDR experience in **Madison, WI** . This is an **open-ended assignment with benefits** ! The Sr. Regulatory Affairs Specialist is responsible for but not limited to:






+ Prepare, submit, and manage regulatory submissions required for device approvals in the US and EU, such as 510(k)s and European Technical Documents in compliance with MDR requirements. This includes the preparation of international documents, including Health Canada submissions and works with Management to ensure rapid and timely approval of new products and continued Regulatory support of marketed products.

+ Function as a Regulatory Affairs subject matter expert for NPD and life cycle projects, providing regulatory strategies, reviewing/approving project documentation, and participating in design control activities for the projects.

+ Evaluate proposed product modifications for global Regulatory impact; and documentation of required change impact assessments and Regulatory Strategies.

+ Develop and implement regulatory strategies and processes to ensure timely global commercialization of NeuWave products in compliance with applicable regulations and standards.

+ Provide regulatory expertise for promotional materials reviews.

+ Prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.

+ Provide guidance to marketing, product development, package engineering & regulatory personnel regarding label content, ensure that product labels & labeling comply with US & foreign government regulations.

+ Support quality system and regulatory audits.

+ Organize & balance a multitude of projects simultaneously to meet aggressive product marketing strategies & be prepared to assist other regulatory professionals with high priority projects as assigned by the department director.

+ Responding to requests from global health authorities for currently marketed products.

+ Managing a significant amount of proprietary information in a confidential manner to prevent loss of intellectual property.

+ Reviewing government, trade association, and industry publications to keep informed of developments that may impact compliance of currently marketed products.

+ Ensure personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.





**Qualifications**




+ Bachelors Degree required, preferably in scientific or technical field

+ 6-8 plus years of experience working within a highly regulated environment, preferably medical devices

+ Minimum 5+ years of direct regulatory affairs experience required

+ Experience writing a 510(k) required

+ MDR experience required

+ Health Canada experience preferred

+ Prior experience with electromechanical devices with software integration preferred

+ Comprehensive expertise in US & foreign government regulations regarding the manufacture & commercial distribution of medical devices

+ Good working skills of MS Office programs (Word, Excel, PowerPoint, Outlook, Adobe Professional) and electronic document management systems

+ Excellent verbal and written communication skills, strong attention to details

+ Strong organizational and project management skills

+ Strong interpersonal, negotiation and problem-solving skills

+ Ability to work independently and collaboratively with minimal supervision

+ Ability to work under pressure within a fast-paced, multi-task team environment, appropriately prioritizing assignments and consistently meeting deadlines

+ Ability & confidence to make appropriate and timely regulatory determinations based upon global regulatory expertise as well as project prioritization based on a thorough understanding of business needs





If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!





**This position comes with enhanced benefits which include:**




+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

+ Paid holidays

+ Paid sick days and vacation days*





**Perks of being a Kelly employee:**




+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Online application system

+ Never an applicant fee





*benefits to be received upon meeting eligibility requirements





**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.**






**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
Posted: 2019-08-09 Expires: 2019-09-09

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Sr. Regulatory Affairs Specialist

Kelly Services
Madison, WI 53703

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