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16 days old

Regulatory Affairs Director

Kelly Services
Ann Arbor, MI 48104
**Kelly Science & Clinical has a new, permanent opportunity for a RA Director in Ann Arbor, MI! Relocation assistance is provided for qualified individuals,**


**D** **ay to Day Responsibilities:**


+ Generate and implement global regulatory strategies for in vitro diagnostic (IVD) products.

+ Develop strategies for development, submission and registration for IVD products.

+ Lead communications and submissions with Regulatory Authorities

+ Direct solutions for specific country regulations and guidelines

+ Develop and generate Regulatory Affairs processes for the Global organization

+ Research and identify issues that may increase risk and prepare strategies to address such risks accordingly

+ Other duties as requested


**Qualifications:**


+ Must have 6-10 years of experience in IVD regulatory affairs

+ Must have at least 5 years of experience in a leadership role with demonstrated experience in successful pre-market submissions

+ Must obtain knowledge of regulatory processes in the US, Canada and EU for commercialization of IVD products. Knowledge in RoW or RAC, given preference

+ Must have extensive knowledge in IVD medical devices, software and instruments

+ Must have understanding of global regulatory, government affairs, and FDA, QSR and ISO 13485.

+ Must have strong leadership skills

+ Strong verbal and written skills, ability to lead cross-functionally

+ Highly organized

+ Thrives in a fast-paced, goal-driven environment


**Salary will range between $150k-$185k, based on title, education, and related Industry experience. If you, or someone you know would like to be considered for this opportunity, please apply online today to discuss the next steps.**


**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: 2022-05-11 Expires: 2022-06-11

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Regulatory Affairs Director

Kelly Services
Ann Arbor, MI 48104

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