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Kelly Services Associate Regulatory Affairs Specialist in Alpharetta, Georgia

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as an Associate Regulatory Affairs Specialist at a prestigious Fortune 500® company working in Alpharetta, GA.

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” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.

Job Title: Associate Regulatory Affairs Specialist

Pay: $34.75 per hour depending on experience

Summary :

Support regulatory compliance throughout the organization by performing the required activities that assure compliance with domestic and international regulations. Help refine and maintain systems for organizing and retrieving regulatory related information.

  1. Maintain regulatory affairs files (e.g. scan, print, file)

  2. Research, renew and obtain State Licensing where needed for the I-Flow facility.

  3. Support and participate in audits performed by internal and external (e.g., FDA, Notified Body, etc) representatives.

  4. Support the implementation of regulatory activities throughout the I-Flow facility.

  5. Assist in preparation and execution of Field Action activities.

  6. Provide regulatory support for International Registrations, DMRs, Technical files, Design Dossiers, etc.

  7. Support MDR Analyst with Medical Device Reporting (MDRs) and Medical Vigilance Reporting (MDVs).

The Associate RA Specialist gathers data and required documents in support of international submission purposes as well as maintains Regulatory databases for ready reference of international and domestic regulatory staff. Incumbent applies technical quality and regulatory protocols and methods to ensure activities are in compliance with company standards and regulatory requirements. They also provide SME Regulatory Leadership for Responsible/Assigned Medical products.

Responsibilities

• Global Product registrations, assessing changes to existing registrations, and maintaining registrations current for assigned products/geographies

• Demonstrate a strong degree of knowledge in excel spreadsheet maintenance, use of outlook tools, SharePoint, and other computer programs used for tracking and reference.

• Maintain records and documents for established systems that support regulatory activities and requirements.

• Strong attention to detail, highly organized, and able to manage multiple projects simultaneously

• Lead projects/initiatives

• Develop and remain current on applicable internal procedures/process(s) and applicable regulations

• Execute and manage technical and scientific regulatory activities

• Effectively communicate, prepare, and manage regulatory submissions, and must assure that deadlines are met

• Remain current on International Regulations and Standards in accordance with role and/or projects

Requirements

• Bachelor´s degree

• Demonstrated computer skills and strong written and verbal communications

• International submission experience preferred/primary author (Canada, Latin America, EMEA, APAC).

• Understanding and experience with process, manufacturing, product development, engineer, market research, marketing and legal matters involving medical device industry, preferred.

We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com at http://www.kellyservices.com/ .

Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.

Kelly Services is an Equal Opportunity Employer

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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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