Quality-Regulatory Affairs Associate

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Job description

Kelly Services is looking to hire a Quality-Regulatory Affairs Associate to work for one of our top Medical Device clients on-site in Ohio for a full-time, direct hire, fully benefited position. This is a high visibility and upward mobility position that has great potential to turn into a leadership position down the line.

Our client is a privately held, Cleveland, Ohio based medical device company committed to providing surgeons with user-friendly, cost-effective devices to protect and repair nerve intraoperatively across the anatomy. Our client's mission is to provide their patients with surgical outcomes that preserve and restore optimal nerve function.

Mission: Advancing the science and practice of nerve protection and repair to improve the quality of life for patients and physicians.

Vision: To be the preeminent nerve protection and repair enterprise.

Values: Excellence, Passion, Purpose, Urgency, Service, Integrity, Respect.

Duties and responsibilities:

• Assist the Sr. Quality-Regulatory Specialist in releasing final product to market.

• Oversee Quality Management System (QMS).

• Identify quality risks and contingency planning for assigned projects.

• Reviews product development to assure collection of appropriate data for regulatory submissions and regulatory compliance.

• Work with Senior Specialist on regulatory timelines, coordinating technical information from appropriate sources and managing the preparation of responses to regulatory agency questions and/or requests for information.

• Apply understanding of the quality systems to job activities and projects.

• Leading post-market surveillance activities such as complaint handling, NCR, and CAPAs.

Qualifications:

• Bachelor's degree in a science, mathematics, engineering, or other technical field is required

• 1+ years of progressive experience in regulatory affairs and/or QA is highly preferrable

• Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook) is required

• Technical capacity including decision making, communication and reporting

• Strong interpersonal communication skill-set and a team-player is a must

• Very detail-oriented and organized is a must

• Prior knowledge of 21CFR 820, ISO13485, MDD and MDR QMS is highly preferrable

• Experience with medical device products is highly preferrable, or previous experience in highly regulated industry such as aeronautical or automotive is a plus

• Experience with 510(k) submissions and CE Technical files is a plus

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.

Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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