1+ months

Sr. Regulatory Affairs Specialist

Kelly Services
Ann Arbor, MI 48104
**Kelly Science & Clinical has a new permanent opportunity for a Sr. Regulatory Affairs Specialist!**

**Day to Day Responsibilities:**

+ Review product specification sheets, or test methods for compliance with applicable regulations and policies

+ Prepare, compile and complete submissions to FDA and EU regulatory entities

+ Review clinical protocols to ensure collection of data needed for regulatory submissions.

+ Write or update regulatory standard operating procedures, work instructions, or policies.

+ Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.

+ Develop and maintain product regulatory requirements and documentation templates to support submissions.

+ Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats.

+ Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

+ Other duties as requested


+ MS in Biochemistry, Microbiology, Molecular Biology or a related field

+ Must have a minimum of 5 years relevant work experience

+ Experience in IVD industry, given preference

+ Experience with regulatory submissions, such as 510(k) and PMA submissions

+ Experience with CE Mark Technical File and Design Dossier submissions for medical devices

+ Experience in regulatory labeling

+ Ability to prepare and present concise information in a group setting

+ Highly organized

+ Thrives in a team-oriented and goal-driven environment

+ Strong analytical and problem-solving skills

**Pay will range between $92k-100k, based on education, and related experience. If you, or someone you know, would like to be considered 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** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise 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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-08-22 Expires: 2022-10-22

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Sr. Regulatory Affairs Specialist

Kelly Services
Ann Arbor, MI 48104

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