Kelly Services Outsourcing & Consulting Group is seeking a Regulatory Affairs Manager for an immediately opening in Chaska, MN. This is a long-term salaried assignment with benefits. The Regulatory Affairs Manager is a staff-level individual contributor who will function as a Subject Matter Expert to help answer questions, write and review 510k submissions, write and review technical files, work with global registries, new product development, track metrics and timelines, help facilitate agency questions and responses. There will not be any line management or budgeting responsibilities.
• Collaborate with Program Managers and technical staff to determine action items and deliverables.
• Track and report status of regulatory deliverables to Program Managers and leadership.
• Liaison with external regulatory agencies.
• Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval for new products and/or changes to existing products.
• Secure necessary country licenses (country approvals), certificates (e.g. CFGs, COE), and renewals (e.g. CE renewals) required to market company's products in that geography.
• Ensure company complies with the local regulatory requirements of the country in which the product is marketed.
• Prepare the necessary documentation, and secure necessary approvals.
• Respond to regulatory agency inquiries.
• Apply and/or write the following certificates: FDA Certificates to Government and Export Certificates, Certificates of Free Sales, and Declaration of Conformity.
• Manage legalization, Apostille, and notarization process.
• Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.
• Bachelor's degree in Science, Regulatory Affairs, or Engineering with 5+ years exp. OR Master's degree in Science, Regulatory Affairs, or Engineering with 3+ years exp.
Medical Technologist background and IVD experience strongly desired
• Excellent organizational skills and attention to detail.
• Strong work ethic with an ability to work independently.
• Possess an ability to read, understand, and summarize technical and scientific information.
• Ability to interpret and apply regulations to company policies and procedures.
• Demonstrated ability to review and approve design control documentation such as verification and validation test protocols/reports, risk management reports, and product labeling.
• Pragmatic with strong problem-solving skills.
• Experience working with cross-functional product development teams to ensure regulatory compliance.
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 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 requirement
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just 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, 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. 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.
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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