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Regulatory Specialist
The purpose of the Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.
Key Responsibilities
- Preparing and maintaining FDA pre-market submissions, Canadian device license applications and international product registrations for medical devices.
- Assist in preparing and submitting MDD Class III Design Dossiers for review by the Notified Body.
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Providing regulatory support for new product development projects:
- Design team participation
- Design Control requirements
- CE marking requirements / Technical File (STED) / Design Dossier compilation
- Pre-market regulatory submissions
- Canadian device license applications
- International product registrations – STED File organization
- Product labeling review and approval
- Ensuring that company procedures, processes and documentation meet the required guidelines for maintaining FDA compliance and ISO/EC/CMDR certification, including the application of Design Control and Risk Management processes.
- Participate as needed in the complaint handling, corrective and preventive action and internal quality audit processes.
- Knowing and applying Exactech’s Quality Management System and any appropriate federal and international standards.
- Providing knowledge and support to the company’s different business units to enable operation within company and regulatory guidelines.
- Assisting and supporting other employees, teams, and sales personnel as necessary.
- Practicing Exactech’s Values.
Skills Knowledge and Expertise
Education:
- Bachelor’s Degree from an accredited institution required.
Experience:
- Minimum 2 years experience in FDA/ISO medical devices quality management system standards required
- 2 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations preferred
Functional/Technical Knowledge, Skills and Abilities Required:
- Technical writing skills required
- Experience in Design Controls
- Working knowledge of windows-based office productivity tools including word processor and spreadsheet
Exactech について
About Exactech
Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn, VuMedi, YouTube, Twitter and Instagram.
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