Senior Specialist, Regulatory Affairs and Compliance

Nordson Medical, a global leader in Interventional Solutions, Fluid Components, and Surgical Solutions, is seeking an experienced and highly motivated individual to join our team. We are committed to creating a diverse and inclusive workplace, and we are looking for candidates who share that same commitment.

Summary of the role

As a member of our team, you will have the opportunity to work in a dynamic and collaborative environment, where your ideas and contributions will be valued and respected.

Employer: Quest Medical, Inc.

Job Title: Senior Regulatory Specialist

Job Location: One Allentown Parkway, Allen, TX 75002

Job Type: Full-time, 40 hours a week, Monday – Friday

Duties: Provide regulatory guidance to product development teams on strategic planning to support optimal timelines for product launches. Lead the submission of licenses and authorizations for the maintenance of existing products, international registrations, and Technical Files. Guide conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials. Help to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams. Prepare regulatory strategies and maintain submissions for U.S. and International markets, including but not limited to 510(k)s and Technical Files, to ensure timely approval of devices and continued regulatory support of marketed devices. Review and summarize post-market surveillance feedback, such as customer feedback, adverse event reporting, customer surveys, trade shows, and publications. Evaluate and document all alleged reportable events and field action reviews/assessments. Prepare and submit all MDRs and associated documentation to the FDA and adverse event reports to other countries within the required timeframes. Follow-up, as required, for failure investigations associated with reportable events. Interact with the FDA and other regulatory authorities on all MDR or reportable events. Maintain and prepare device registrations, listings, certifications, export certificates, and Declarations of Conformity. Responsible for understanding and complying with current domestic and international regulatory requirements, including but not limited to FDA, European, and Canadian requirements. Act as a Regulatory Affairs representative on core product development teams. Communicate regulatory requirements and impact of regulations to the development teams. Review design history files to ensure all regulatory requirements are being met. Review and provide regulatory authorization for labeling, marketing literature, and protocols/reports for compliance with regulatory requirements. Evaluate, investigate, document and communicate with both the FDA and/or other regulatory authorities on all product recalls. Write all recall communications to the field and customers. Document and reconcile product inventory associated with recall. Follow up with corrective action associated with recall issue. Provide oversight of third party testing (UL, EMC, biocompatibility, sterilization assurance) as required. Manage or execute a timely and effective internal audit program. Review processes for compliance to appropriate regulations and internal procedures. Provide support for external audits conducted by Quest customers, regulatory authorities, and Notified Bodies. Position requires 10% domestic and 5% international travel.

Requirements: Bachelor's degree in Regulatory Affairs, Healthcare Policy, Healthcare Management, or related field and five (5) years of experience as a Senior Regulatory Affairs Specialist, International Regulatory Affairs Specialist, Regulatory Affairs Specialist, Regulatory Affairs Co-Ordinator, or related role where experience was gained. Also requires experience in the following:

• Three years of experience in Medical device Regulatory Affairs;
• Three years of experience in Medical device Class II/III;
• FDA QSR, ISO13485, MDD, Health Canada, and other applicable U.S. and International regulations;
• FDA Quality System Regulation, ISO13485, CMDR, MDD, and ISO 14971;
• Preparing and filing reportable events (MDRs) and Vigilance Reports;
• FDA regulatory submissions and CE marking; and
• Interacting with regulatory bodies, such as the FDA and Notified Body.

Alternatively, will accept a Master's degree in Regulatory Affairs, Healthcare Policy, Healthcare Management, or related field and three (3) years of experience as a Senior Regulatory Affairs Specialist, International Regulatory Affairs Specialist, Regulatory Affairs Specialist, Regulatory Affairs Co-Ordinator, or related role where experience was gained, plus the special skills listed above.

SALARY: $124,400 per year

Contact: Quest Medical, Inc. at [email protected] and reference: job title and location.

This Notice is being provided as a result of the filing of an application for permanent alien labor certification for the opportunity. Any person may provide documentary evidence bearing on the application to: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210

Interested?

If you are interested in being a part of a team and creating an inclusive and diverse workplace, please apply online with your CV.

About Nordson Medical

At Nordson MEDICAL, you don't have to be a doctor to help save lives. We are the global expert in the design, development, and manufacturing of complex medical devices and component technologies. By joining our team today, you will help us bring innovative ideas to life. Nordson MEDICAL is a global team that works to create components for life-saving medical devices. We offer a supportive culture in a growing and dynamic work environment. Whether you're just beginning your career or you're a seasoned professional, there's a place for you to belong at Nordson MEDICAL. We offer hourly and salary positions in production, maintenance, customer service, quality, engineering, and more. We actively invest in our teams to help you build your skillsets and advance your career.