26 days old

Regulatory Affairs Specialist

Kelly Services
Raritan, NJ 08869

Responsible for ensuring documents submitted with changes conform to established standards and providing support to the Document and Change Control process.


+ Process Change Orders according to appropriate procedures

+ Review Change Orders for accuracy and completion and provide feedback to originators

+ Assist in delivering training to internal customers on Change Order process

+ Revise Document and Change Control related documents for style, grammar, spelling, format and assess

+ impact it may have on other documents

+ Assist in Non-Conformance Reports and CAPAs

+ Other responsibilities as required or assigned by manager



+ Bachelor degree or equivalent experience

+ 2+ years of experience in medical device manufacturing industry

+ Strong computer skills and use of software application(s), including Microsoft Windows and Office applications (i.e., Word, Excel, PowerPoint, etc.)

+ Knowledge of general medical device requirements

+ Ability to work under pressure in a dynamic, fast-paced environment

+ Ability to multi-task and interact well with others

+ Good attention to detail

+ Work with U.S., EU, and International regulatory affairs activities for Project MDR.

+ Collaborate with cross-functional project team members and commercial partners to oversee the regulatory aspects of MDR Management project changes and ensure the project timelines are met and in compliance with world-wide regulations and Directives.

+ Prepare US, EU, and International Regulatory impact assessments for design, packaging, manufacturing, and labeling changes.

+ Prepare submissions to U.S., EU, and international health authorities, as required.

+ Ensure all regulatory documents are complete, accurate, and well-maintained.

+ Prepare regulatory labeling requirements specifications for new and modified products and review product labeling to ensure compliance.

+ Respond to product information requests.

+ Research and collect information and data to support periodic reports to regulatory agencies

+ Represent Regulatory Affairs on cross-functional project teams

+ Deliver documents in response to MDRIM requests to support NPD registrations and registrations in Wave 1 and 2a markets.

**This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.** .

+ Provide required documentation and reporting.


+ Experience on Microsoft Access and SolidWorks

+ Process Excellence Green Belt Certification with demonstrated problem-solving skills

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (


Posted: 2022-05-30 Expires: 2022-06-30

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Regulatory Affairs Specialist

Kelly Services
Raritan, NJ 08869

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