Careers

Key Responsibilities

Functional Oversight and Management:

• Provide functional oversight of Regulatory Affairs, Quality Assurance, Manufacturing, Product Engineering, Field Service, and R&D activities, ensuring alignment with company priorities and applicable regulatory and quality requirements.
• Directly supervise the Quality Systems Manager and Field Service and Product Engineering Manager, providing guidance, prioritization, and support while maintaining appropriate functional ownership within each area.
• Monitor key activities, issues, risks, and project status across these functions and provide regular updates to senior management.
• Facilitate cross-functional decision-making and escalation of significant quality, regulatory, manufacturing, service, or product-development issues.
• Support resource planning, prioritization, and coordination of activities necessary to maintain regulatory approvals, product quality, manufacturing continuity, and product-development objectives.

Regulatory Affairs:

• Maintain knowledge of applicable U.S. and international medical device regulations, standards, and guidance, including FDA requirements, ISO 13485, ISO 14971, IEC 60601 series standards, MDSAP, EU MDR, and other applicable market-specific requirements.
• Prepare, coordinate, and maintain U.S. and international regulatory submissions, registrations, licenses, and technical documentation, including FDA submissions and international market approvals.
• Manage ongoing regulatory activities for marketed devices, including registration renewals and amendments, responses to regulatory questions and questions and requests for additional information, and coordination with regulatory authorities, distributors, authorized representatives, consultants, and other international regulatory partners.
• Evaluate and document the regulatory impact of proposed product, design, software, manufacturing, supplier, labeling, and process changes and determine whether regulatory notification, submission, additional testing, or other regulatory action is required prior to implementation.
• Review and approve product labeling, Instructions for Use (IFUs), specifications, marketing materials, and other product documentation for consistency with applicable regulatory requirements and cleared/approved intended uses.
• Support regulatory strategy and requirements for new products, accessories, product improvements, and entry into new international markets, including identification of applicable standards, testing, documentation, and submission requirements.
• Coordinate regulatory activities involving external test laboratories and other technical resources to obtain applicable safety, performance, EMC, software, or other testing and documentation needed to support regulatory compliance and market approvals.
• Monitor changes to applicable regulations and standards, assess their potential impact on existing products and registrations, and coordinate implementation of necessary actions.
• Maintain regulatory records and documentation in accordance with Aesthetics Biomedical's QMS and ensure regulatory commitments and requirements are appropriately communicated to affected functions.

Quality Assurance:

• Perform responsibilities in accordance with Aesthetics Biomedical's ISO 13485-certified QMS and MDSAP requirements.
• Support internal and external audits and certification activities, including audit preparation, auditor correspondence, responses to findings, and implementation of corrective actions as needed.
• Participate in CAPA, nonconformance, complaint, and change-control activities when regulatory or technical input is required.
• Participate in product risk-management activities in accordance with ISO 14971.
• Support Post-Market Surveillance and regulatory reporting activities as needed, including evaluation of post-market information for potential regulatory notification or reporting requirements.
• Ensure regulatory and engineering activities are appropriately documented within the QMS.

Engineering, Manufacturing, and Field Service Support:

• Support engineering activities involving product and design changes, manufacturing improvements, supplier technical issues, and ongoing product development.
• Prepare and support engineering change documentation and design-control activities, including technical risk assessments and verification and validation of hardware, software, manufacturing, and product changes.
• Assist with investigation and troubleshooting of manufacturing nonconformities, product failures, complaints, and field service issues, including root-cause investigation and implementation of appropriate technical corrections.
• Support manufacturing and field service activities as needed, including process/equipment validation, production troubleshooting, supplier and contract manufacturer support, and complex device troubleshooting or repair.

Qualifications

• Bachelor's degree in Biomedical Engineering or a related technical discipline. Advanced degree preferred.
• 5+ years of experience in regulatory affairs within the medical device industry.
• Familiarity with ISO 13485, MDSAP, ISO 14971, QMSR, and IEC 60601 preferred.
• Understanding of medical device design controls, verification and validation, and engineering change processes preferred.
• Strong technical troubleshooting, analytical, and problem-solving skills.
• Strong technical writing, documentation, and organizational skills.
• Ability to work cross-functionally with Regulatory, Quality, Engineering, Manufacturing, Field Service, suppliers, contract manufacturers, test laboratories, and international partners.