Kelly Services Sr. Regulatory Affairs Associate _ Remote in Atlanta, Georgia
Kelly Services is currently seeking a Sr. Regulatory Affairs Associate for one of our top clients in Atlanta, GA. This position can be 100% Remote.
Duration: 6 -8 months
Provide technical leadership in the development and implementation of regulatory strategies of glove products to support the achievement of business objectives for client business units, while ensuring compliance with domestic and international regulations. Provide a regulatory perspective and input to other functions on safety and quality issues for a cohesive response to the business units that will ensure corporate compliance with the regulations. Provide regulatory training and strategic regulatory assessments to the research and development teams in support of new technology development within the glove product line that are cognizant of product testing and other requirements for regulatory approval in global markets.
Expectations and Responsibilities: .
Assist and document domestic product specific regulatory strategies.
Assist in the preparation of accurate regulatory submissions to secure timely approvals in support of business initiatives.
Monitor the development of regulatory initiatives and communicate potential business impact to direct manager.
Provide an interpretation of regulatory requirements, both domestic and international to the appropriate business team members and highlight implications of differences with respect to product development and testing activities to minimize overall development activities while bringing speed to the global registration process.
Anticipate and assist in the resolution of regulatory and/or quality issues and recommends corrective action.
Assist with regulatory inquiries to ensure that registrations and approvals are granted without delay.
Participate in review of unregulated products to ensure boundary adherence.
This individual provides analytical, interpretive and evaluative solutions to complex problems through specialized regulatory expertise based on an in-depth knowledge of technical and business practices. The incumbent integrates and coordinates activities within clearly defined policies; helps develop and champion regulatory policies; relies on an ability to understand and motivate people without direct authority; and is responsible for providing services to client business(es).
The main challenges of the position are:
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.
Having the ability to understand issues pertaining to use of chemicals of concern as identified by regulatory agencies
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.
Assist with regulatory strategies and assessments for the glove product line to ensure successful achievement of business objectives.
Actively participate in the IMF process by providing targeted feedback on proposed product designs to ensure that potential regulatory hurdles and/or public relations issues are identified at the earliest stages of a project and appropriate business decisions can be made.
Ensure regulatory submissions, such as those for FDA and Health Canada are prepared and submitted accurately, completely and in a timely manner to meet business objectives.
Ensure compliance and effective product lifecycle management of North American products.
Provide advice to staff and global manufacturing facilities regarding compliance with FDA and Health Canada Quality System and GMP requirements
Lead the resolution of regulatory and/or quality issues and non-compliances.
Participate in the review of process/product changes, labeling, claims, complaints, etc., to ensure compliance to internal QMS, FDA, Health Canada as well as with international regulatory agency requirements and provide notification to regulatory authorities as required.
Serve as a liaison internally with R&E, marketing, legal and other regulatory resources throughout the Enterprise as well as externally with FDA and Heath Canada agencies and international health ministries and notified body/certification body organizations.
Evaluate suppliers and contract manufacturers for adherence to applicable regulations
Work with consultants as needed to drive regulatory deliverables
Review non-regulated products to ensure business is adhering to regulatory boundaries
Perform all other regulatory functions as requested by the Team Leader.
Demonstrate company behaviors in all business interactions to ensure that the GRA team attracts, develops and retains the best people and fosters an environment which motivates a diverse team to fully use its capabilities in achieving desired business results.
A broad technical background is required; preferably a bachelor’s degree within a major scientific discipline and 3-5 years of relevant technical experience or a graduate level degree with 0-2 years of relevant experience.
Relevant experience must include prior medical device experience including authoring or assisting with FDA 510(k) and Health Canada device submissions.
Must have knowledge of QSR/GMP regulations.
Must possess an understanding of the product development process and understand the aspects of global product launches.
Must have exceptional writing and communication skills.
Experience with OTC Monograph drugs, cosmetics and Natural Health Products is a plus. Understanding of Prop 65 requirements is a plus.
Experience with Class I Medical Devices (Class II desired) and need to have worked on product development/introduction.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Email email@example.com for questions about the position but please apply online to be considered for the position.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly Learning Center
Weekly pay and service bonus plans
Group-rate insurance options available immediately upon hire*
*Available for purchase and administered by a designated third-party vendor
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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 (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)