Regulatory Affairs and Quality Systems Manager

Description

Position Summary: The incumbent is responsible for leading NeoSoft's regulatory affairs and quality management programs to ensure compliance with applicable medical device regulations and quality standards worldwide. This role oversees product registrations, quality systems, audits, document control, and regulatory support throughout the product lifecycle.

Job Duties and Responsibilities:

• Leads regulatory affairs and quality management activities to ensure compliance with FDA, ISO 13485, MDR, Health Canada, and other applicable global regulations.
• Manages the preparation, submission, maintenance, and renewal of domestic and international medical device registrations, licenses, and technical documentation.
• Develops and implements regulatory strategies and compliance plans to support new product development and product changes.
• Manages the Quality Management System (QMS), including CAPA, document control, internal audits, and post-market surveillance activities.
• Plans, coordinates, and leads internal, customer, and regulatory audits and inspections while ensuring timely resolution of findings.
• Monitors changes in global regulatory requirements, communicates business impacts, and implements necessary compliance actions.
• Reviews and approves product labeling, technical documentation, and regulatory submissions to ensure regulatory compliance.
• Collaborates with engineering, manufacturing, and product development teams to integrate regulatory and quality requirements throughout the product lifecycle.
• Serves as the primary contact for regulatory agencies, notified bodies, customers, and external regulatory partners.
• Identifies regulatory and clinical data requirements for product approvals and provides regulatory guidance to support business objectives.
• Executes core duties and responsibilities of the role in accordance with the established skills competencies.

Requirements

Essential Skills and Experience:

• Bachelor's degree in Engineering, Science, or a related field.
• Minimum five (5) years of regulatory affairs experience in the medical device industry within the FDA and ISO 13485 regulated environment.
• Demonstrated experience preparing and maintaining global medical device registrations and regulatory submissions.
• Direct experience with SaMD and Medical Device Software (MDSW).
• Hands-on experience preparing EU MDR technical documentation.
• Strong knowledge of applicable medical device regulations and standards, including FDA, ISO 13485, ISO 14971, MDR, MDSAP, and related requirements.
• Experience managing quality systems, CAPA, internal audits, document control, and regulatory inspections.
• Excellent written and verbal communication skills with the ability to work effectively across all levels of the organization.
• Strong analytical, problem-solving, organizational, and project management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, Outlook).

Preferred Qualifications:

• Experience with cardiac imaging, radiology software, or diagnostic imaging systems.
• Familiarity with DICOM standards and cardiac clinical workflows.

Reporting to this position: No direct reports

Physical demands and work environment: The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Physical demands: While performing duties of job, employee is frequently required to type, sit, stand; walk; use hands, talk and hear; occasionally reach with hands and arms. Employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Work Environment: The noise level in the work environment is minimal.