Job Description
If you are an experienced Regulatory Affairs Specialist looking for a position with a leading company, Bartech can help! We are a leading staffing firm and our clients include some of the biggest companies in the nation. Our client has a need for a Regulatory Affairs Specialist. This is a contract position; however it is not uncommon for assignments to transition into permanent positions with our client companies. If you have the background we are looking for, and you are interested in an opportunity to get your foot in the door with leading company, we want to talk with you!
Applicant must be eligible to work in the US for immediate opening. For this opportunity, the successful candidate will be directly employed by Bartech Staffing as a W2 employee while providing services to our end client.
Regulatory Affairs Specialist
Job Responsibilities
Your specific duties as a Regulatory Affairs Specialist will include:

• Job Title: Regulatory Affairs Specialist
• Location: Neenah, WI
• Pay Rate: $46/hour.
• Length: 1 year contract (eligible to extend)
• Schedule: 100% Remote; however, preference will be given to Hybrid candidates local to Neenah, WI
• Provide regulatory support in the development and implementation of regulatory strategies to achieve business objectives for North America Business, while ensuring compliance with the US FDA and Health Canada Class I medical devices, Consumer Products and Cosmetics regulations.
• Provide regulatory assessments to the research and engineering (R&E) teams in support of design controls and change management in cognizant of product testing and other requirements for regulatory compliance.
• Provide regulatory support on Labeling and Ad Promo (Artwork/copy doc.) reviews and approvals.
• Provide regulatory support with procedures/SOP development and continuous improvements.
• Make regulatory impact assessment on Advance Warning Assessment Tool.
• Primary (internal) customers include all cross functional teams for the KC North America Adult Feminine Care, Family Care, and Baby & Child Care business units including R&E, Legal, Quality, Regulatory, Product Safety, and Marketing.
• Participate and work independently on project teams developing/launching products by defining regulatory requirements and necessary regulatory deliverables to ensure compliance and successful achievement of business objectives.
• Actively participate in the Innovation management process by providing targeted feedback on proposed product designs to ensure potential regulatory hurdles are identified at the earliest stages of a project and appropriate business decisions can be made.
• Assess regulatory pathway for new product platforms and product modifications; Develop regulatory strategies, regulatory summaries, assessments, and tactical plans to ensure compliance with FDA and Health Canada regulatory requirements.
• Responsible for monitoring, interpreting, and implementing current and new regulatory requirements for U.S and Canada. Followed by appropriate preventive communication and training within the business units.
• Provide consultation and guidance relative to the resolution of regulatory and/or quality issues and non-compliances.
• Support product change management, complete product claims reviews, labeling/ingredient reviews to ensure regulatory compliance.
• Establish and maintain an information network for the purposes of monitoring domestic and international regulatory developments, followed by appropriate preventive communication and training within the business units.
• Collaborate with Research and Engineer, Marketing, and legal teams in the development of compliant medical device labeling and product claims.
• Provide advice and counsel to staff and global manufacturing facilities regarding compliance with FDA, Health Canada Quality System requirements, as well as international and national standards, when necessary.
• 10. Support the regulatory intelligence monitoring program by assessing changes in regulation and determining impact to K-C medical device products

Regulatory Affairs Specialist
Job Requirements
As a Regulatory Affairs Specialist you must represent our company well by being responsible, punctual and motivated to go above and beyond the call of duty. You must also be highly detail-oriented and organized with excellent analytic and problem-solving abilities. It is also important that you display excellent verbal and written communication and interpersonal skills.

• Understanding the various domestic and international business needs.
• Understanding and interpreting domestic and international regulations relative to new technology, and product development.
• Having the ability to understand the technical aspects of the vast array of regulated products manufactured and/or marketed by the business units.
• Have the insight to problem-solve proactively on regulatory and associated quality issues.
• Understanding various regulatory options for rapid commercialization of new technologies while keeping the businesses informed of costs, timing, and competitive access.
• Comply with policies, internal controls, and global regulations.
• Regulatory experiences on Class I Medical Device, Consumer Products and Cosmetic Products.
• A bachelor’s degree in a life science discipline and 5 to 7 years of relevant regulatory experience, including FDA and Health Canada regulations.
• Understanding of US FDA Design Controls Process including product design/formulation, manufacturing, engineering, marketing, and legal matters.

Regulatory Affairs Specialist
Benefits

As a Regulatory Affairs Specialist with Bartech, you will be working through an established and respected staffing organization with over 40 years of serving as a trusted partner to our client companies. We are dedicated to providing our talent with personal, responsive attention, and will assign an employee care representative to answer any questions or concerns that you might have. Depending upon the client, the assignment and your performance, you can find potential opportunities for direct employment. Your hard work and professional dedication will be rewarded with competitive compensation, including benefits.
Available benefits for Regulatory Affairs Specialist Position may include (but are not limited to):

• Exceptional medical, dental, and vision
• 401(k)

Make the most of your experience!
Apply now!
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