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15 days old

Regulatory Specialist

Kelly Services
Rochester, NY 14651
**Regulatory Specialist**


Kelly Services has provided outstanding employment opportunities to the most talented individuals in the marketplace. Today, we are proud to offer a long-term contract opportunity for a Regulatory Specialist with our client, a leader in the Medical Device industry, located in Rochester, NY.


Day shift - 40 hours a week until the end of the year- Likely to extend


Work under the direct supervision of senior regulatory professionals in the collection and collation of materials required for various submissions. May provide a preliminary review of product technical information, certification documentation, and master file documents. Position may support other regulatory activities as required.


+ Prepare product submissions such as 51O(k), annual reports, technical

+ files, and other country-specific documents.

+ Maintain regulatory files.

+ Provide technical assistance to obtain documents and research applicable requirements to allow for the evaluation and impact assessment for submission filing decisions.

+ Assist in the review and approval of product labeling including advertising and promotional materials.


This position involves interfacing with internal departments such as Research and Development, Manufacturing, Legal Counsel, Quality Clinical Research, Marketing and Commercial Strategy.


**Requirements**


+ BS/MS in a technical or scientific discipline required.

+ Minimum 1-3 years' experience in medical device and/or pharmaceutical industry with experience in Quality or Regulatory disciplines a plus.

+ Good analytical and organization skills required.

+ Must demonstrate strong communication and interactive skills and be able to work independently or on project teams as required to execute assignments with precision and timeliness.

+ Computer literacy required.

+ Must possess at least a fundamental level of performance in the following core competencies: influence key stakeholders, business acumen, project management, relationship building and regulatory expertise.


Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.


**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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2022-06-10 Expires: 2022-07-11

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Regulatory Specialist

Kelly Services
Rochester, NY 14651

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