Regulatory Affairs Specialist - REMOTE

Associate Kelly Outsourcing & Consulting Group is seeking candidates for a REMOTE Regulatory Affairs Specialist. This is an open-ended assignment and comes with enhanced benefits. The Senior Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on regulatory programs. The incumbents primary responsibilities will be the evaluation, coordination, preparation and implementation of pre-market Regulatory Affairs activities.Responsibilities may include:t

Administration and setup of template FDA and agency submissions for IVD projects.t

Planning and implementing pre-market registration, reporting and compliance activities in accordance with the development center business plans.t

Implementing global regulatory compliance programs for product corrective action and/or adverse event reporting.t

Preparing premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.t

Additionally, may provide assistance to technical departments, manufacturing business centers and suppliers in the creation and structuring of clinical data for pre-market notifications.

Educational requirements:t

Bachelors degree in field with 3-5+ years exp.t

Medical Technologist background and IVD experience strongly desired.t

510K submission writing experiencet

New product development experiencet

Experience with Analytical Instrumentationt

Experience working with global registries

This position comes with enhanced benefits which include:t

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

Paid holidayst

Paid sick days and vacation days

Perks of being a Kelly employee:t

Weekly electronic payt

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

Online application systemt

Never an applicant fee

benefits to be received upon meeting eligibility requirementsImportant 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.Why Kelly ® ?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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm#KellyGTS