Director, Quality & Regulatory

ALKU; Boston (MA); Híbrido; USD 180.000 - 260.000; Jornada completa

Descripción de la vacante

ALKU in Boston is seeking a Director of Quality and Regulatory to lead the quality team and oversight of regulatory operations for electromechanical capital systems and consumables. The role guides design controls, regulatory strategy, and post-market activities, ensuring alignment with FDA and global requirements.

The position requires expertise across QMS, CAPA, MDR, and risk management, with experience in inspections and submissions.

Formación

• Demonstrated experience leading Quality and Regulatory Compliance programs within the medical device industry.
• Strong working knowledge of FDA medical device regulations including 21 CFR Part 820, Design Controls, CAPA, MDR, and Post-Market Surveillance.
• Experience supporting FDA inspections, ISO 13485 certification audits, and regulatory submissions.
• Proven ability to manage regulatory compliance activities across product development, manufacturing, commercialization, and post-market surveillance.
• Experience with risk management methodologies, including ISO 14971, preferred.
• Regulatory affairs certification (RAC) or CQE/CQA preferred.

Responsabilidades

• Provide strategic leadership and oversight of the company's Quality Management System (QMS) and Regulatory Compliance programs.
• Serve as the primary quality representative during regulatory inspections, audits, and interactions with regulatory agencies, including the FDA.
• Develop and execute regulatory strategies supporting product development, approvals, labeling changes, and post-market requirements.
• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, MDR, CAPA, risk management, and international regulations.
• Oversee internal and external audit programs, supplier quality management, and inspection readiness initiatives.
• Provide guidance on regulatory risks, remediation activities, and quality system improvements.
• Lead quality and regulatory review for design controls, verification/validation, software validation, change control, and product lifecycle management.
• Establish quality metrics and report status to executive leadership.
• Maintain relationships with regulatory agencies, auditors, consultants, and industry bodies.

Conocimientos

Strategic leadership

Regulatory compliance

FDA regulations

Quality management

Cross-functional leadership

Educación

Bachelor's degree in Engineering, Life Sciences, or related field

RAC or CQE/CQA preferred

Herramientas

QMS systems

Regulatory submissions

FDA inspections

Descripción del empleo

The Director, Quality and Regulatory will lead the quality team in developing and executing Quality and regulatory operations in line with the Company's mission and vision. The Director will implement and monitor all company quality systems to demonstrate compliance with FDA requirements and applicable global regulations. This position is responsible for providing quality and regulatory guidance for design, development, manufacturing, commercialization, and post-market activities for electromechanical capital systems and consumables. The Director will oversee Quality Assurance, Quality Systems, Regulatory Compliance, inspection readiness, and interactions with regulatory authorities to ensure the organization maintains a state of continuous compliance. This is a hybrid role, expectations are to be in our Woburn, MA office 4 days per week, with flexibility 1 day remote.

Add to Essential Duties and Responsibilities

• Provide strategic leadership and oversight of the company's Quality Management System (QMS) and Regulatory Compliance programs.
• Serve as the primary quality representative during regulatory inspections, audits, and interactions with regulatory agencies, including the FDA, notified bodies, auditors, and other applicable authorities.
• Develop and execute regulatory strategies supporting product development, product approvals, labeling changes, and post-market requirements.
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, Medical Device Reporting (MDR), complaint handling, CAPA, risk management, and applicable international regulations.
• Oversee internal and external audit programs, supplier quality management, and inspection readiness initiatives.
• Provide guidance regarding regulatory risks, compliance gaps, remediation activities, and quality system improvements.
• Lead quality and regulatory review activities related to design controls, verification and validation, software validation, change management, and product lifecycle management.
• Ensure effective management of complaints, adverse events, corrective actions, and field actions in accordance with applicable regulatory requirements.
• Establish quality and compliance metrics, monitor organizational performance, and communicate results to executive leadership.
• Develop and maintain relationships with regulatory agencies, external auditors, consultants, and industry organizations to stay current on evolving regulatory requirements and industry best practices.
• Maintain, prepare, 510K submissions.

Education and Experience

• Demonstrated experience leading Quality and Regulatory Compliance programs within the medical device industry.
• Strong working knowledge of FDA medical device regulations, including 21 CFR Part 820, Design Controls, CAPA, Complaint Handling, MDR, and Post-Market Surveillance requirements.
• Experience supporting FDA inspections, ISO 13485 certification audits, and regulatory submissions.
• Proven ability to manage regulatory compliance activities across product development, manufacturing, commercialization, and post-market surveillance.
• Experience with risk management methodologies, including ISO 14971, preferred.
• RAC (Regulatory Affairs Certification), ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), or similar certification preferred.

Additional Accountability Section

Regulatory and Compliance Oversight

• Own the company's quality and compliance framework, ensuring ongoing adherence to FDA, ISO, state, federal, and international regulatory requirements.
• Identify, assess, and mitigate regulatory risks that may impact business operations, product approvals, or market access.
• Report quality and regulatory compliance status, risks, trends, and remediation plans to executive leadership.
• Drive a culture of quality, compliance, continuous improvement, and inspection readiness throughout the organization.