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7 days old

Regulatory Affairs Specialist II

Kelly Services
Miami, FL 33126
Kelly Science & Clinical is currently seeking a **Remote Regulatory Affairs Specialist II** for a long-term engagement with one of our Global Med Device clients out of Miami, FL


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


**Duties & Responsibilities:**

Ensures compliance with regulatory agency regulations and interpretations.

Gathers and assembles information necessary for submissions in

accordance with regulations and relevant procedures.

Involved with the preparation of necessary outlines, summaries, status reports,

memos, graphs, charts, tables to support regulatory submissions.

Reviews documents to ensure all agency and quality standards are met.

Researches, collects data, and responds to requests from regulatory agencies

and/or distributors to prepare and submit documentation for marketing approvals,

as well as to provide routine regulatory information to associates and affiliates.

Support regulatory labeling requirements specifications for new and modified

products, and reviews product labeling to ensure compliance.

Provides regulatory guidance to project teams and responds to

product information requests.

Assists in the development of best practices for Regulatory Affairs processes.

Represents Regulatory Affairs on cross-functional project teams.

Responsible for communicating business related issues or opportunities to next

management level

Responsible for ensuring personal and Company compliance with all Federal,

State, local and Company regulations, policies, and procedures

Performs other duties assigned as needed


**Experience and Education**

Bachelor degree with 1-3 years of experience in related field and/or equivalent

experience in the medical device industry

Practical experience in a medical device Regulatory Environment, preparing

regulatory submissions for Class II and III medical devices in the US and

EU and other markets.

Knowledge of US and European regulatory processes is required.

Knowledge of international medical device requirements (China, Japan, Australia, Brazil,

Russia, etc.) is preferred.

Experience working as a member of a team in a timeline-driven environment with

limited supervision is required.

Prior interaction with the FDA and Notified Bodies is preferred and other

worldwide agencies preferred.


**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)
Posted: 2021-06-11 Expires: 2021-07-12

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Regulatory Affairs Specialist II

Kelly Services
Miami, FL 33126

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