Kelly Scientific wants a top notch medical device regulatory affairs specialist near Akron, OH.
The Regulatory Affairs Specialist supports the product portfolio, manufacturing operations, customer needs and P & L objectives of the company by contributing to all phases of the product life-cycle as required. This includes providing regulatory guidance, registering products, evaluating engineering changes with respect to regulatory compliance, maintaining required Regulatory records and reports, maintaining compliant complaint tracking and CAPA systems and interacting with regulatory agencies and notified bodies. This individual will be expected to utilize semi-advanced knowledge of the regulatory environment and business principles while soliciting assistance from more senior regulatory staff members and working under the direct supervision of the Regulatory Affairs Manager.
Duties and responsibilities
- Assist in establishing and maintaining Regulatory functions and systems to ensure continuous medical device and environmental regulatory compliance.
- Assist in maintaining the Quality Management System to ensure domestic and international standards are met.
- Create and maintain company quality documentation such as quality manuals and quality procedures.
- Define and document corporate regulatory practices within the Quality Management System to maintain compliance with applicable regulatory agencies.
- Support the development of new and revised products through the analysis of applicable regulations and the creation and implementation of the appropriate regulatory strategies.
- Register new products with the appropriate agencies and organizations and maintain the registrations of existing products according to the applicable regulatory strategies.
- Provide guidance to the Engineering staff on the creation and maintenance of Design History Files (DHF), Device Master Records (DMR) and technical files.
- Provide technical assistance to other departments in the determination of testing requirements to comply with medical device and electrical safety regulations.
- Maintain the complaint tracking system and analyze complaints regularly for trends to determine improvements to Design and Safety.
- Evaluate as well as possible reportable adverse event complaints incidents that may need reported to applicable agencies.
- Maintain the Corrective And Preventive Action (CAPA) system and all associated CAPA files in compliance with applicable regulations.
- Participate in the support of external audits performed by notified bodies, regulatory agencies, customers and business partners.
- Participate as a QMS internal auditor to maintain ISO13485 compliance.
- Interface with cross-functional teams on large and small projects to ensure products are transferred to production in accordance with cGMPs, QSRs, MDRs and the Quality Management System.
- Author, review, analyze and approve validations as appropriate.
- Provide assistance interdepartmentally in the formal assessment of risk in accordance to published regulations and/or customer expectations.
- Strive for continuous improvements to the regulatory processes.
- Communicate regularly and effectively with cross-functional personnel in order to achieve desired objectives.
- Complete special projects as assigned by the Regulatory Affairs Manager.
- Adhere to and promote all organizational policies and procedures.
The minimum qualifications listed below are representative of the knowledge, skill, and/or ability needed in order to successfully perform the job.
- Bachelor’s degree in a science, mathematics, engineering or other technology field is required
- 1-3 years of progressive experience in regulatory affairs required
- Appropriate combination of education and experience may also be acceptable
- Prior knowledge of 21CFR 820, ISO13485 and MDD QMS requirements preferred
- Experience with medical device products preferred
- ASQ, Six Sigma, RAPS or other regulatory certifications preferred
- Proficient in Microsoft Office Suite (Word, Excel, Project, Visio, Power Point, Outlook)
- Problem solving/analysis including statistical process control
- Technical capacity including decision making, communication and reporting
- Strong interpersonal communication skill set
- Organizational skills
Apply today or refer a friend!
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.