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14 days old

Senior Regulatory Affairs Specialist

Kelly Services
Blue Ash, OH 45242
Kelly Science & Clinical is currently seeking a **Remote Senior Regulatory Affairs Specialist** for a long-term engagement with one of our Global Med Device clients out of Ohio


*****This role is fully remote*****


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, Vision, 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.


**Position Duties & Responsibilities:**

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 on a monthly basis

Represent Regulatory Affairs on cross functional Lifecycle project teams

Collaborate with affiliates and other internal SMEs to support Lifecycle activities such as change control and Regulatory reregistrations

Manage new Appian requests for Regulatory renewals and new product introductions

Update RA data, databases and systems as required by Lifecycle projects

Complete Technical File Biannual reviews

Maintenance of EU Technical Files, Design Dossiers and Technical Documentation as required


**Education & Experience Requirements:**

Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration

Must have at least 5-8 years of Regulatory Affairs experience in the medical device industry.

Must have working knowledge of U.S., E.U., and International Regulatory requirements and be able to apply this knowledge to ensure that all projects maintain compliance to worldwide regulatory requirements.

Must have previous experience with document management systems and change control systems.

Must be able to work independently, utilizing research and problem-solving skills, and the willingness to learn new skills.

Must have excellent Global written, verbal communication and presentation skills.

Must be able to communicate clearly, succinctly, and effectively.

Must have solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive.

Must be able to work in a timeline-driven environment.


**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: 2021-09-13 Expires: 2021-10-14

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Senior Regulatory Affairs Specialist

Kelly Services
Blue Ash, OH 45242

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