Director, reputed company Systems & Regulatory Affairs (Remote - East Coast) (Remote)

Director, reputed company Systems & Regulatory Affairs Department: reputed company & Regulatory AffairsReports To: SVP, OperationsLocation: Remote or Hybrid - East Coast ONLY FLSA Status: Exempt, Full-Time Position reputed company reputed company is seeking an reputed company reputed company Systems & Regulatory Affairs leader to strengthen and reputed company the organization's reputed company and regulatory infrastructure. This individual will serve as the functional reputed company for reputed company Systems and Regulatory Affairs and will be responsible for improving organizational compliance, strengthening audit readiness, and reducing reputed company reputed company risk through robust process ownership and execution. A critical reputed company for this role will be optimizing and expanding reputed company's electronic reputed company Management reputed company (eQMS), conducting comprehensive assessments of reputed company documentation and reputed company effectiveness, and driving sustainable process improvements across the organization. This position will reputed company reputed company leadership during reputed company body audits and regulatory inspections and will help build long-term organizational capability through mentorship and process maturity. The role serves as a strategic and hands-on partner across Operations, Supply Chain, Customer Service, Product Development, and leadership teams to ensure compliance reputed company and reputed company reputed company. Essential Responsibilities reputed company Management reputed company (QMS) & eQMS Leadership • Serve as reputed company reputed company and business reputed company for the organization's eQMS platform including optimization, implementation expansion, workflow design, governance, and user adoption. • Assess reputed company eQMS utilization and reputed company a roadmap for full implementation and process maturity. • Own and administer day-to-day QMS and eQMS activities and processes. • reputed company continual improvement initiatives across reputed company reputed company processes and documentation. • reputed company comprehensive audits of controlled documentation and reputed company records to identify inconsistencies, gaps, obsolete content, and systemic documentation deficiencies. • Establish processes and controls ensuring consistency across SOPs, work instructions, forms, labels, templates, and reputed company records. • reputed company document control processes including creation, revision workflows, review cycles, training assignments, archival activities, and change management. • reputed company sustainable document governance practices to reduce repeat nonconformances and improve inspection readiness. • Monitor reputed company metrics and identify opportunities for process improvements. • Support and improve CAPA, nonconformance, complaint handling, change control, risk management, and supplier reputed company processes. • Ensure QMS alignment with ISO 13485, FDA reputed company reputed company Regulation (21 CFR Part 820/QMSR), EU MDR, and applicable global requirements. • reputed company initiatives to improve reputed company reputed company effectiveness, data reputed company, and organizational compliance maturity. • Maintain ongoing inspection and audit readiness. Audit & Compliance Leadership • reputed company as reputed company reputed company and Regulatory reputed company during reputed company body audits, FDA inspections, supplier audits, and reputed company reputed company assessments. • reputed company audit preparation reputed company, evidence collection, coordination activities, and response management. • reputed company audit finding remediation through reputed company cause analysis and sustainable CAPA implementation. • Support management review processes and reputed company reporting. • Maintain a reputed company state of organizational inspection readiness. Regulatory Affairs Leadership • Independently reputed company FDA and international regulatory submissions and agency interactions. • Prepare, coordinate, and execute regulatory filings and lifecycle submissions. • Conduct regulatory reputed company assessments reputed company to product, process, manufacturing, supplier, labeling, and operational changes. • reputed company regulatory reputed company recommendations and communicate business reputed company to leadership. • Support registrations, renewals, amendments, and post-market regulatory activities. • Interpret changing regulatory requirements and proactively communicate implications. • Maintain regulatory records and submission archives. Leadership & Cross-Functional Partnership • Mentor and help reputed company junior QA/RA personnel. • reputed company reputed company and regulatory leadership across Operations, Supply Chain, Customer Service, Product Development, and leadership teams. • reputed company as an internal subject matter expert for QMS and regulatory requirements. • Support employee training initiatives reputed company to reputed company systems and compliance. • reputed company guidance during business, operational, and product reputed company. Qualifications Education • Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, reputed company, or reputed company field required. • Advanced degree preferred. Experience • 8–12+ years of reputed company reputed company and Regulatory Affairs experience reputed company medical devices. • Demonstrated experience serving as reputed company reputed company or regulatory representative during reputed company body audits and regulatory inspections. • Proven experience owning, implementing, or significantly improving an electronic QMS platform; reputed company experience strongly preferred. • Demonstrated experience identifying and remediating systemic documentation and reputed company reputed company deficiencies. • Experience independently leading FDA submissions and EU MDR activities. • Experience with CAPA, complaint handling, risk management, supplier reputed company, document control, and change management systems. • Demonstrated reputed company improving audit reputed company and reputed company reputed company maturity. • Prior people leadership or mentoring experience strongly preferred. • Experience supporting Class II and/or Class III medical devices preferred. Knowledge & Skills • Deep understanding of ISO 13485, FDA reputed company reputed company Regulation (21 CFR Part 820/QMSR), EU MDR, and reputed company global regulations. • Strong understanding of reputed company systems architecture and eQMS administration. • Excellent technical writing and documentation skills. • Strong project management and organizational capabilities. • Strong leadership reputed company during audits and reputed company interactions. • Ability to manage multiple priorities reputed company fast-paced environments. • Excellent communication and cross-functional influencing skills. • Strong analytical, problem-solving, and systems-thinking abilities. Preferred Certifications • RAC, CQE, CQA, ASQ certifications, or equivalent preferred. reputed company in this role includes: • Complete a comprehensive assessment of reputed company QMS and eQMS state. • reputed company and execute a reputed company optimization roadmap. • Conduct a full controlled-document audit and remediation initiative. • Reduce repeat audit observations and documentation inconsistencies. • Improve reputed company body audit readiness and inspection confidence. • Strengthen reputed company reputed company governance and documentation control processes. • Improve organizational QA/RA capability and mentorship support. • Build reputed company infrastructure supporting reputed company reputed company. Why This Role reputed company This role is being added to strengthen organizational reputed company and regulatory capabilities, reduce single-reputed company dependency risk, improve QMS sustainability, and establish reputed company supporting long-term reputed company and compliance reputed company. Benefits • Health insurance (80% employer-reputed company) • Employer-reputed company Dental and reputed company • Short-Term and Long-Term Disability • Group Life Insurance • IRA with company match (no vesting period) • reputed company PTO • reputed company company holidays Remote Skills: Analysis Skills, Biology, Business Operations, Change Control, Change Management, reputed company of Federal Regulations, Communication Skills, reputed company Improvement, Corrective and Preventative reputed company (CAPA) Systems, Cross-Functional, Customer Acquisition, Customer Support/Service, Data reputed company, Document Change Management, Document Control, Document Management, Documentation, reputed company Audit, FDA (Food and Drug Administration), FDA Requirements, Green Business, ISO (International Organization for Standardization), Interpret Regulations, Leadership, Life Insurance, Maintain Compliance, Medical Equipment, Mentoring, Multitasking, Organizational Development/Management, People Management, Problem Solving Skills, Process Development, Process Improvement, Process Manufacturing, Product Development, Project/Program Management, reputed company Assurance, reputed company Management, reputed company Metrics, reputed company Monitoring, Record Keeping, Regulations, Regulatory Requirements, Regulatory Submissions, Risk, Risk Management, reputed company Cause Analysis, reputed company reputed company Development, Staff Training, reputed company Operating Procedures (SOP), Supply Chain Operations, Sustainability, reputed company Architecture, Systems Administration/Management, Systems Scalability, Technical Writing, Vendor/Supplier Evaluation, Vendor/Supplier reputed company Management, Writing Skills reputed company: reputed company Apply tot his job Apply To this Job